Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model

Summary

The FDA issued a Class II for Alinity ci-series System Control Module clinical chemistry and immunoassay analy by Abbott Laboratories. Reason: Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents .

Details

Product Description

Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

Lot/Code Info: Model Number: LN 03R70-01 all units with software versions 3.2.3 and earlier. Serial Numbers manufactured by Sanmina: SCM01001; SCM01002; SCM01003; SCM01004; SCM01005; SCM01006; SCM01007; SCM01008; SCM01009; SCM01010; SCM01011; SCM01012; SCM01013; SCM01014; SCM01015; SCM01016; SCM01017; SCM01018; SCM01019; SCM01020; SCM01021; SCM01022; SCM01023; SCM01024; SCM01025; SCM01026; SCM01027; SCM01028; SCM01029; SCM01030; SCM01031; SCM01032; SCM01033; SCM01034; SCM01035; SCM01036; SCM01037; SCM01038; SCM01039; SCM01040; SCM01041; SCM01042; SCM01043; SCM01044; SCM01045; SCM01046; SCM01047; SCM01048; SCM01049; SCM01050; SCM01051; SCM01052; SCM01053; SCM01054; SCM01055; SCM01056; SCM01057; SCM01058; SCM01059; SCM01060; SCM01061; SCM01062; SCM01063; SCM01064; SCM01065; SCM01066; SCM01067; SCM01068; SCM01069; SCM01070; SCM01071; SCM01072; SCM01073; SCM01074; SCM01075; SCM01076; SCM01077; SCM01078; SCM01079; SCM01080; SCM01081; SCM01082; SCM01083; SCM01084; SCM01085; SCM01086; SCM01087; SCM01088; SCM01089; SCM01090; SCM01091; SCM01092; SCM01093; SCM01094; SCM01095; SCM01096; 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SCM01600; SCM01601; SCM01602; SCM01603; SCM01604; SCM01605; SCM01606; SCM01607; SCM01608; SCM01609; SCM01610; SCM01611; SCM01612; SCM01613; SCM01614; SCM01615; SCM01616; SCM01617; SCM01618; SCM01619; SCM01620; SCM01621; SCM01622; SCM01623; SCM01624; SCM01625; SCM01626; SCM01627; SCM01628; SCM01629; SCM01630; SCM01631; SCM01632; SCM01633; SCM01634; SCM01635; SCM01636; SCM01637; SCM01638; SCM01639; SCM01640; SCM01641; SCM01642; SCM01643; SCM01644; SCM01645; SCM01646; SCM01647; SCM01648; SCM01649; SCM01650; SCM01651; SCM01652; SCM01653; SCM01654; SCM01655; SCM01656; SCM01657; SCM01658; SCM01659; SCM01660; SCM01661; SCM01662; SCM01663; SCM01664; SCM01665; SCM01666; SCM01667; SCM01668; SCM01669; SCM01670; SCM01671; SCM01673; SCM01674; SCM01675; SCM01676; SCM01677; SCM01678; SCM01679; SCM01680; SCM01681; SCM01682; SCM01683; SCM01684; SCM01685; SCM01686; SCM01687; SCM01688; SCM01689; SCM01690; SCM01691; SCM01692; SCM01693; SCM01694; SCM01695; SCM01696; SCM01697; SCM01698; SCM01699; SCM01700; SCM01701; SCM01702; SCM01703; SCM01704; SCM01705; SCM01706; SCM01707; SCM01708; SCM01709; SCM01710; SCM01711; SCM01712; SCM01713; SCM01714; SCM01715; SCM01716; SCM01717; SCM01718; SCM01719; SCM01720; SCM01721; SCM01722; SCM01723; SCM01724; SCM01725; SCM01726; SCM01727; SCM01728; SCM01729; SCM01730; SCM01731; SCM01732; SCM01733; SCM01734; SCM01735; SCM01736; SCM01737; SCM01738; SCM01739; SCM01740; SCM01741; SCM01742; SCM01743; SCM01744; SCM01745; SCM01746; SCM01747; SCM01748; SCM01749; SCM01750; SCM01751; SCM01752; SCM01753; SCM01754; SCM01755; SCM01756; SCM01757; SCM01758; SCM01759; SCM01760; SCM01761; SCM01762; SCM01763; SCM01764; SCM01765; SCM01766; SCM01767; SCM01768; SCM01769; SCM01770; SCM01771; SCM01772; SCM01773; SCM01774; SCM01775; SCM01776; SCM01777; SCM01778; SCM01779; SCM01780; SCM01781; SCM01782; SCM01783; SCM01784; SCM01785; SCM01786; SCM01787; SCM01788; SCM01789; SCM01790; SCM01791; SCM01792; SCM01793; SCM01794; SCM01795; SCM01796; SCM01797; SCM01798; SCM01799; SCM01800; SCM01801; SCM01802; SCM01803; SCM01804; SCM01805; SCM01806; SCM01807; SCM01808; SCM01809; SCM01810; SCM01811; SCM01812; SCM01813; SCM01814; SCM01815; SCM01816; SCM01817; SCM01818; SCM01819; SCM01820; SCM01821; SCM01822; SCM01823; SCM01824; SCM01825; SCM01826; SCM01827; SCM01828; SCM01829; SCM01830; SCM01831; SCM01832; SCM01833; SCM01834; SCM01835; SCM01836; SCM01837; SCM01838; SCM01839; SCM01840; SCM01841; SCM01842; SCM01843; SCM01844; SCM01845; SCM01846; SCM01847; SCM01848; SCM01849; SCM01850; SCM01851; SCM01852; SCM01853; SCM01854; SCM01855; SCM01856; SCM01857; SCM01858; SCM01859; SCM01860; SCM01861; SCM01862; SCM01863; SCM01864; SCM01865; SCM01866; SCM01867; SCM01868; SCM01869; SCM01870; SCM01871; SCM01872; SCM01873; SCM01874; SCM01875; SCM01876; SCM01877; SCM01878; SCM01879; SCM01880; SCM01881; SCM01882; SCM01883; SCM01884; SCM01885; SCM01886; SCM01887; SCM01888; SCM01889; SCM01890; SCM01891; SCM01892; SCM01893; SCM01894; SCM01895; SCM01896; SCM01897; SCM01898; SCM01899; SCM01900; SCM01901; SCM01902; SCM01903; SCM01904; SCM01905; SCM01906; SCM01907; SCM01908; SCM01909; SCM01910; SCM01911; SCM01912; SCM01913; SCM01914; SCM01915; SCM01916; SCM01917; SCM01918; SCM01919; SCM01920; SCM01921; SCM01922; SCM01923; SCM01924; SCM01925; SCM01926; SCM01927; SCM01928; SCM01929; SCM01930; SCM01931; SCM01932; SCM01933; SCM01934; SCM01935; SCM01936; SCM01937; SCM01938; SCM01939; SCM01940; SCM01941; SCM01942; SCM01943; SCM01944; SCM01945; SCM01946; SCM01947; SCM01948; SCM01949; SCM01950; SCM01951; SCM01952; SCM01953; SCM01954; SCM01955; SCM01956; SCM01957; SCM01958; SCM01959; SCM01960; SCM01961; SCM01962; SCM01963; SCM01964; SCM01965; SCM01966; SCM01967; SCM01968; SCM01969; SCM01970; SCM01971; SCM01972; SCM01973; SCM01974; SCM01975; SCM01976; SCM01977; SCM01978; SCM01979; SCM01980; SCM01981; SCM01982; SCM01983; SCM01984; SCM01985; SCM01986; SCM01987; SCM01988; SCM01989; SCM01990; SCM01991; SCM01992; SCM01993; SCM01994; SCM01995; SCM01996; SCM01997; SCM01998; SCM01999; SCM02000; SCM02001; SCM02002; SCM02003; SCM02004; SCM02005; SCM02006; SCM02007; SCM02008; SCM02009; SCM02010; SCM02011; SCM02012; SCM02013; SCM02014; SCM02015; SCM02016; SCM02017; SCM02018; SCM02019; SCM02020; SCM02021; SCM02022; SCM02023; SCM02024; SCM02025; SCM02026; SCM02027; SCM02028; SCM02029; SCM02030; SCM02031; SCM02032; SCM02033; SCM02034; SCM02035; SCM02036; SCM02037; SCM02038; SCM02039; SCM02040; SCM02041; SCM02042; SCM02043; SCM02044; SCM02045; SCM02046; SCM02047; SCM02048; SCM02049; SCM02050; SCM02051; SCM02052; SCM02053; SCM02054; SCM02055; SCM02056; SCM02057; SCM02058; SCM02059; SCM02060; SCM02061; SCM02062; SCM02063; SCM02064; SCM02065; SCM02066; SCM02067; SCM02068; SCM02069; SCM02070; SCM02071; SCM02072; SCM02073; SCM02074; SCM02075; SCM02076; SCM02077; SCM02078; SCM02079; SCM02080; SCM02081; SCM02082; SCM02083; SCM02084; SCM02085; SCM02086; SCM02087; SCM02088; SCM02089; SCM02090; SCM02091; SCM02092; SCM02093; SCM02094; SCM02095; SCM02096; SCM02097; SCM02098; SCM02099; SCM02100; SCM02101; SCM02102; SCM02103; SCM02104; SCM02105; SCM02106; SCM02107; SCM02108; SCM02109; SCM02110; SCM02111; SCM02112; SCM02113; SCM02114; SCM02115; SCM02116; SCM02117; SCM02118; SCM02119; SCM02120; SCM02121; SCM02122; SCM02123; SCM02124; SCM02125; SCM02126; SCM02127; SCM02128; SCM02129; SCM02130; SCM02131; SCM02132; SCM02133; SCM02134; SCM02135; SCM02136; SCM02137; SCM02138; SCM02139; SCM02140; SCM02141; SCM02142; SCM02143; SCM02144; SCM02145; SCM02146; SCM02147; SCM02148; SCM02149; SCM02150; SCM02151; SCM02152; SCM02153; SCM02154; SCM02155; SCM02156; SCM02157; SCM02158; SCM02159; SCM02160; SCM02161; SCM02162; SCM02163; SCM02164; SCM02165; SCM02166; SCM02167; SCM02168; SCM02169; SCM02170; SCM02171; SCM02172; SCM02173; SCM02174; SCM02175; SCM02176; SCM02177; SCM02178; SCM02179; SCM02181; SCM02182; SCM02183; SCM02184; SCM02185; SCM02186; SCM02187; SCM02188; SCM02189; SCM02190; SCM02191; SCM02192; SCM02193; SCM02194; SCM02195; SCM02196; SCM02197; SCM02198; SCM02199; SCM02200; SCM02201; SCM02202; SCM02203; SCM02204; SCM02205; SCM02206; SCM02207; SCM02208; SCM02209; SCM02210; SCM02211; SCM02212; SCM02213; SCM02214; SCM02215; SCM02216; SCM02217; SCM02218; SCM02219; SCM02220; SCM02221; SCM02222; SCM02223; SCM02224; SCM02225; SCM02226; SCM02227; SCM02228; SCM02229; SCM02230; SCM02231; SCM02232; SCM02233; SCM02234; SCM02235; SCM02236; SCM02237; SCM02238; SCM02239; SCM02240; SCM02241; SCM02242; SCM02243; SCM02244; SCM02245; SCM02246; SCM02247; SCM02248; SCM02249; SCM02250; SCM02251; SCM02252; SCM02253; SCM02254; SCM02255; SCM02256; SCM02257; SCM02258; SCM02259; SCM02260; SCM02261; SCM02262; SCM02263; SCM02264; SCM02265; SCM02266; SCM02267; SCM02268; SCM02269; SCM02270; SCM02271; SCM02272; SCM02273; SCM02274; SCM02275; SCM02276; SCM02277; SCM02278; SCM02279; SCM02280; SCM02281; SCM02282; SCM02283; SCM02284; SCM02285; SCM02286; SCM02287; SCM02288; SCM02289; SCM02290; SCM02291; SCM02292; SCM02293; SCM02294; SCM02295; SCM02296; SCM02297; SCM02298; SCM02299; SCM02300; SCM02301; SCM02302; SCM02303; SCM02304; SCM02305; SCM02306; SCM02307; SCM02308; SCM02309; SCM02310; SCM02311; SCM02312; SCM02313; SCM02314; SCM02315; SCM02316; SCM02317; SCM02318; SCM02319; SCM02320; SCM02321; SCM02322; SCM02323; SCM02324; SCM02325; SCM02326; SCM02327; SCM02328; SCM02329; SCM02330; SCM02331; SCM02332; SCM02333; SCM02334; SCM02335; SCM02336; SCM02337; SCM02338; SCM02339; SCM02340; SCM02341; SCM02342; SCM02343; SCM02344; SCM02345; SCM02346; SCM02347; SCM02348; SCM02349; SCM02350; SCM02351; SCM02352; SCM02353; SCM02354; SCM02355; SCM02356; SCM02357; SCM02358; SCM02359; SCM02360; SCM02361; SCM02362; SCM02363; SCM02364; SCM02365; SCM02366; SCM02367; SCM02368; SCM02369; SCM02370; SCM02371; SCM02372; SCM02373; SCM02374; SCM02375; SCM02376; SCM02377; SCM02378; SCM02379; SCM02380; SCM02381; SCM02382; SCM02383; SCM02384; SCM02385; SCM02386; SCM02387; SCM02388; SCM02389; SCM02390; SCM02391; SCM02392; SCM02393; SCM02394; SCM02395; SCM02396; SCM02397; SCM02398; SCM02399; SCM02400; SCM02401; SCM02402; SCM02403; SCM02404; SCM02405; SCM02406; SCM02407; SCM02408; SCM02409; SCM02410; SCM02411; SCM02412; SCM02413; SCM02414; SCM02415; SCM02416; SCM02417; SCM02418; SCM02419; SCM02420; SCM02421; SCM02422; SCM02423; SCM02424; SCM02425; SCM02426; SCM02427; SCM02428; SCM02429; SCM02430; SCM02431; SCM02432; SCM02433; SCM02434; SCM02435; SCM02436; SCM02437; SCM02438; SCM02439; SCM02440; SCM02441; SCM02442; SCM02443; SCM02444; SCM02445; SCM02446; SCM02447; SCM02448; SCM02449; SCM02450; SCM02451; SCM02452; SCM02453; SCM02454; SCM02455; SCM02456; SCM02457; SCM02458; SCM02459; SCM02460; SCM02461; SCM02462; SCM02463; SCM02464; SCM02465; SCM02466; SCM02467; SCM02468; SCM02469; SCM02470; SCM02471; SCM02472; SCM02473; SCM02474; SCM02475; SCM02476; SCM02477; SCM02478; SCM02479; SCM02480; SCM02481; SCM02482; SCM02483; SCM02484; SCM02485; SCM02486; SCM02487; SCM02488; SCM02489; SCM02490; SCM02491; SCM02492; SCM02493; SCM02494; SCM02495; SCM02496; SCM02497; SCM02498; SCM02499; SCM02500; SCM02501; SCM02502; SCM02503; SCM02504; SCM02505; SCM02506; SCM02507; SCM02508; SCM02509; SCM02510; SCM02511; SCM02512; SCM02513; SCM02514; SCM02515; SCM02516; SCM02517; SCM02518; SCM02519; SCM02520; SCM02521; SCM02522; SCM02523; SCM02524; SCM02525; SCM02526; SCM02527; SCM02528; SCM02529; SCM02530; SCM02531; SCM02532; SCM02533; SCM02534; SCM02535; SCM02536; SCM02537; SCM02538; SCM02539; SCM02540; SCM02541; SCM02542; SCM02543; SCM02544; SCM02545; SCM02546; SCM02547; SCM02548; SCM02549; SCM02550; SCM02551; SCM02552; SCM02553; SCM02554; SCM02555; SCM02556; SCM02557; SCM02558; SCM02559; SCM02560; SCM02561; SCM02562; SCM02563; SCM02564; SCM02565; SCM02566; SCM02567; SCM02568; SCM02569; SCM02570; SCM02571; SCM02572; SCM02573; SCM02574; SCM02575; SCM02576; SCM02577; SCM02578; SCM02579; SCM02580; SCM02581; SCM02582; SCM02583; SCM02584; SCM02585; SCM02586; SCM02587; SCM02588; SCM02589; SCM02590; SCM02591; SCM02592; SCM02593; SCM02594; SCM02595; SCM02596; SCM02597; SCM02598; SCM02599; SCM02600; SCM02601; SCM02602; SCM02604; SCM02605; SCM02606; SCM02607; SCM02608; SCM02609; SCM02610; SCM02611; SCM02612; SCM02613; SCM02614; SCM02615; SCM02616; SCM02617; SCM02618; SCM02619; SCM02620; SCM02621; SCM02622; SCM02623; SCM02624; SCM02625; SCM02626; SCM02627; SCM02628; SCM02629; SCM02630; SCM02631; SCM02632; SCM02633; SCM02634; SCM02635; SCM02637; SCM02638; SCM02639; SCM02640; SCM02641; SCM02642; SCM02643; SCM02644; SCM02645; SCM02646; SCM02647; SCM02648; SCM02649; SCM02650; SCM02651; SCM02652; SCM02653; SCM02654; SCM02655; SCM02656; SCM02657; SCM02658; SCM02659; SCM02660; SCM02661; SCM02662; SCM02663; SCM02664; SCM02665; SCM02666; SCM02667; SCM02668; SCM02669; SCM02670; SCM02671; SCM02672; SCM02673; SCM02674; SCM02675; SCM02676; SCM02677; SCM02678; SCM02679; SCM02680; SCM02681; SCM02682; SCM02683; SCM02684; SCM02685; SCM02686; SCM02687; SCM02688; SCM02689; SCM02690; SCM02691; SCM02692; SCM02693; SCM02694; SCM02695; SCM02696; SCM02697; SCM02698; SCM02699; SCM02700; SCM02701; SCM02702; SCM02703; SCM02704; SCM02705; SCM02706; SCM02707; SCM02708; SCM02709; SCM02710; SCM02711; SCM02712; SCM02713; SCM02714; SCM02715; SCM02716; SCM02717; SCM02718; SCM02719; SCM02720; SCM02721; SCM02722; SCM02723; SCM02724; SCM02725; SCM02726; SCM02727; SCM02728; SCM02729; SCM02730; SCM02731; SCM02732; SCM02733; SCM02734; SCM02735; SCM02736; SCM02737; SCM02738; SCM02739; SCM02740; SCM02741; SCM02742; SCM02743; SCM02744; SCM02745; SCM02746; SCM02747; SCM02748; SCM02749; SCM02750; SCM02751; SCM02752; SCM02753; SCM02754; SCM02755; SCM02756; SCM02757; SCM02758; SCM02759; SCM02760; SCM02761; SCM02762; SCM02763; SCM02764; SCM02765; SCM02766; SCM02767; SCM02768; SCM02769; SCM02770; SCM02771; SCM02772; SCM02773; SCM02774; SCM02775; SCM02776; SCM02777; SCM02778; SCM02779; SCM02780; SCM02781; SCM02782; SCM02783; SCM02784; SCM02785; SCM02786; SCM02787; SCM02788; SCM02789; SCM02790; SCM02791; SCM02792; SCM02793; SCM02794; SCM02795; SCM02796; SCM02797; SCM02798; SCM02799; SCM02800; SCM02801; SCM02802; SCM02803; SCM02804; SCM02805; SCM02806; SCM02807; SCM02808; SCM02809; SCM02810; SCM02811; SCM02812; SCM02813; SCM02814; SCM02815; SCM02816; SCM02817; SCM02818; SCM02819; SCM02820; SCM02821; SCM02822; SCM02823; SCM02824; SCM02825; SCM02826; SCM02827; SCM02828; SCM02829; SCM02830; SCM02831; SCM02832; SCM02833; SCM02834; SCM02835; SCM02836; SCM02837; SCM02838; SCM02839; SCM02840; SCM02841; SCM02842; SCM02843; SCM02844; SCM02845; SCM02846; SCM02847; SCM02848; SCM02849; SCM02850; SCM02851; SCM02852; SCM02853; SCM02854; SCM02855; SCM02856; SCM02857; SCM02858; SCM02859; SCM02860; SCM02861; SCM02862; SCM02863; SCM02864; SCM02865; SCM02866; SCM02867; SCM02868; SCM02869; SCM02870; SCM02871; SCM02872; SCM02873; SCM02874; SCM02875; SCM02876; SCM02877; SCM02878; SCM02879; SCM02880; SCM02881; SCM02882; SCM02883; SCM02884; SCM02885; SCM02886; SCM02887; SCM02888; SCM02889; SCM02890; SCM02891; SCM02892; SCM02893; SCM02894; SCM02895; SCM02896; SCM02897; SCM02898; SCM02899; SCM02900; SCM02901; SCM02902; SCM02903; SCM02904; SCM02905; SCM02906; SCM02907; SCM02908; SCM02909; SCM02910; SCM02911; SCM02912; SCM02913; SCM02914; SCM02915; SCM02916; SCM02917; SCM02918; SCM02919; SCM02920; SCM02921; SCM02922; SCM02923; SCM02924; SCM02925; SCM02926; SCM02927; SCM02928; SCM02929; SCM02930; SCM02931; SCM02932; SCM02933; SCM02934; SCM02935; SCM02936; SCM02937; SCM02938; SCM02939; SCM02940; SCM02941; SCM02942; SCM02943; SCM02944; SCM02945; SCM02946; SCM02947; SCM02948; SCM02949; SCM02950; SCM02951; SCM02952; SCM02953; SCM02954; SCM02955; SCM02956; SCM02957; SCM02958; SCM02959; SCM02960; SCM02961; SCM02962; SCM02963; SCM02964; SCM02965; SCM02966; SCM02967; SCM02968; SCM02969; SCM02970; SCM02971; SCM02972; SCM02973; SCM02974; SCM02975; SCM02976; SCM02977; SCM02978; SCM02979; SCM02980; SCM02981; SCM02982; SCM02983; SCM02984; SCM02985; SCM02986; SCM02987; SCM02988; SCM02989; SCM02990; SCM02991; SCM02992; SCM02993; SCM02994; SCM02995; SCM02996; SCM02997; SCM02998; SCM02999; SCM03000; SCM03001; SCM03002; SCM03003; SCM03004; SCM03005; SCM03006; SCM03007; SCM03008; SCM03009; SCM03010; SCM03011; SCM03012; SCM03013; SCM03014; SCM03015; SCM03016; SCM03017; SCM03018; SCM03019; SCM03020; SCM03021; SCM03022; SCM03023; SCM03024; SCM03025; SCM03026; SCM03027; SCM03028; SCM03029; SCM03030; SCM03031; SCM03032; SCM03033; SCM03034; SCM03035; SCM03036; SCM03037; SCM03038; SCM03039; SCM03040; SCM03041; SCM03042; SCM03043; SCM03044; SCM03045; SCM03046; SCM03047; SCM03048; SCM03049; SCM03050; SCM03051; SCM03052; SCM03053; SCM03054; SCM03055; SCM03056; SCM03057; SCM03058; SCM03059; SCM03060; SCM03061; SCM03062; SCM03063; SCM03064; SCM03065; SCM03066; SCM03067; SCM03068; SCM03069; SCM03070; SCM03071; SCM03072; SCM03073; SCM03074; SCM03075; SCM03076; SCM03077; SCM03078; SCM03079; SCM03080; SCM03081; SCM03082; SCM03083; SCM03084; SCM03085; SCM03086; SCM03087; SCM03088; SCM03089; SCM03090; SCM03091; SCM03092; SCM03093; SCM03094; SCM03095; SCM03096; SCM03097; SCM03098; SCM03099; SCM03100; SCM03101; SCM03102; SCM03103; SCM03104; SCM03105; SCM03106; SCM03107; SCM03108; SCM03109; SCM03110; SCM03111; SCM03112; SCM03113; SCM03114; SCM03115; SCM03116; SCM03117; SCM03118; SCM03119; SCM03120; SCM03121; SCM03122; SCM03123; SCM03124; SCM03125; SCM03126; SCM03127; SCM03128; SCM03129; SCM03130; SCM03131; SCM03132; SCM03133; SCM03134; SCM03135; SCM03136; SCM03137; SCM03138; SCM03139; SCM03140; SCM03141; SCM03142; SCM03143; SCM03144; SCM03145; SCM03146; SCM03147; SCM03148; SCM03149; SCM03150; SCM03151; SCM03152; SCM03153; SCM03154; SCM03155; SCM03156; SCM03157; SCM03158; SCM03159; SCM03160; SCM03161; SCM03162; SCM03163; SCM03164; SCM03165; SCM03166; SCM03167; SCM03168; SCM03169; SCM03170; SCM03171; SCM03172; SCM03173; SCM03174; SCM03175; SCM03176; SCM03177; SCM03178; SCM03179; SCM03180; SCM03181; SCM03182; SCM03183; SCM03184; SCM03185; SCM03186; SCM03187; SCM03189; SCM03190; SCM03191; SCM03192; SCM03193; SCM03194; SCM03195; SCM03196; SCM03197; SCM03198; SCM03199; SCM03200; SCM03201; SCM03202; SCM03203; SCM03204; SCM03205; SCM03206; SCM03207; SCM03208; SCM03209; SCM03210; SCM03211; SCM03212; SCM03213; SCM03214; SCM03215; SCM03216; SCM03217; SCM03218; SCM03219; SCM03220; SCM03221; SCM03222; SCM03223; SCM03224; SCM03225; SCM03226; SCM03227; SCM03228; SCM03229; SCM03230; SCM03231; SCM03232; SCM03233; SCM03234; SCM03235; SCM03236; SCM03237; SCM03238; SCM03239; SCM03240; SCM03241; SCM03242; SCM03243; SCM03244; SCM03245; SCM03246; SCM03247; SCM03248; SCM03249; SCM03250; SCM03251; SCM03252; SCM03253; SCM03254; SCM03255; SCM03256; SCM03257; SCM03258; SCM03259; SCM03260; SCM03261; SCM03262; SCM03263; SCM03264; SCM03265; SCM03266; SCM03267; SCM03268; SCM03269; SCM03271; SCM03272; SCM03273; SCM03274; SCM03275; SCM03276; SCM03277; SCM03278; SCM03279; SCM03280; SCM03281; SCM03282; SCM03283; SCM03284; SCM03285; SCM03286; SCM03287; SCM03288; SCM03289; SCM03290; SCM03291; SCM03292; SCM03293; SCM03294; SCM03295; SCM03296; SCM03297; SCM03298; SCM03299; SCM03300; SCM03301; SCM03302; SCM03303; SCM03304; SCM03305; SCM03306; SCM03307; SCM03308; SCM03309; SCM03310; SCM03311; SCM03312; SCM03313; SCM03314; SCM03315; SCM03316; SCM03317; SCM03318; SCM03319; SCM03320; SCM03321; SCM03322; SCM03323; SCM03324; SCM03325; SCM03326; SCM03327; SCM03328; SCM03329; SCM03330; SCM03331; SCM03332; SCM03333; SCM03334; SCM03335; SCM03336; SCM03337; SCM03338; SCM03339; SCM03340; SCM03341; SCM03342; SCM03343; SCM03344; SCM03345; SCM03346; SCM03347; SCM03348; SCM03349; SCM03350; SCM03351; SCM03352; SCM03353; SCM03354; SCM03355; SCM03356; SCM03357; SCM03358; SCM03359; SCM03360; SCM03361; SCM03362; SCM03363; SCM03364; SCM03365; SCM03366; SCM03367; SCM03368; SCM03369; SCM03370; SCM03371; SCM03372; SCM03373; SCM03374; SCM03375; SCM03376; SCM03377; SCM03378; SCM03379; SCM03380; SCM03381; SCM03382; SCM03383; SCM03384; SCM03385; SCM03386; SCM03387; SCM03388; SCM03389; SCM03390; SCM03391; SCM03392; SCM03393; SCM03394; SCM03395; SCM03396; SCM03397; SCM03398; SCM03399; SCM03400; SCM03401; SCM03402; SCM03403; SCM03404; SCM03405; SCM03406; SCM03407; SCM03408; SCM03409; SCM03410; SCM03411; SCM03412; SCM03413; SCM03414; SCM03415; SCM03416; SCM03417; SCM03418; SCM03419; SCM03420; SCM03421; SCM03422; SCM03423; SCM03424; SCM03425; SCM03426; SCM03427; SCM03428; SCM03429; SCM03430; SCM03431; SCM03432; SCM03433; SCM03434; SCM03435; SCM03436; SCM03437; SCM03438; SCM03439; SCM03440; SCM03441; SCM03442; SCM03443; SCM03444; SCM03445; SCM03446; SCM03447; SCM03448; SCM03449; SCM03450; SCM03451; SCM03452; SCM03453; SCM03454; SCM03455; SCM03456; SCM03457; SCM03458; SCM03459; SCM03460; SCM03461; SCM03462; SCM03463; SCM03464; SCM03465; SCM03466; SCM03467; SCM03468; SCM03469; SCM03470; SCM03471; SCM03472; SCM03473; SCM03474; SCM03475; SCM03476; SCM03477; SCM03478; SCM03479; SCM03480; SCM03481; SCM03482; SCM03483; SCM03484; SCM03485; SCM03486; SCM03487; SCM03488; SCM03489; SCM03490; SCM03491; SCM03492; SCM03493; SCM03494; SCM03495; SCM03496; SCM03497; SCM03498; SCM03499; SCM03500; SCM03501; SCM03502; SCM03503; SCM03504; SCM03505; SCM03506; SCM03507; SCM03508; SCM03509; SCM03510; SCM03511; SCM03512; SCM03513; SCM03514; SCM03515; SCM03516; SCM03517; SCM03518; SCM03519; SCM03520; SCM03521; SCM03522; SCM03523; SCM03524; SCM03525; SCM03526; SCM03527; SCM03528; SCM03529; SCM03530; SCM03531; SCM03532; SCM03533; SCM03534; SCM03535; SCM03536; SCM03537; SCM03538; SCM03539; SCM03540; SCM03541; SCM03542; SCM03543; SCM03544; SCM03545; SCM03546; SCM03547; SCM03548; SCM03549; SCM03550; SCM03551; SCM03552; SCM03553; SCM03554; SCM03555; SCM03556; SCM03557; SCM03558; SCM03559; SCM03560; SCM03561; SCM03562; SCM03563; SCM03564; SCM03565; SCM03566; SCM03567; SCM03568; SCM03569; SCM03570; SCM03571; SCM03572; SCM03573; SCM03574; SCM03575; SCM03576; SCM03577; SCM03578; SCM03579; SCM03580; SCM03581; SCM03582; SCM03583; SCM03584; SCM03585; SCM03586; SCM03587; SCM03588; SCM03589; SCM03590; SCM03591; SCM03592; SCM03593; SCM03594; SCM03595; SCM03596; SCM03597; SCM03598; SCM03599; SCM03600; SCM03601; SCM03602; SCM03603; SCM03604; SCM03605; SCM03606; SCM03607; SCM03608; SCM03609; SCM03610; SCM03611; SCM03612; SCM03613; SCM03614; SCM03615; SCM03616; SCM03617; SCM03618; SCM03619; SCM03620; SCM03621; SCM03622; SCM03623; SCM03624; SCM03625; SCM03626; SCM03627; SCM03628; SCM03629; SCM03630; SCM03631; SCM03632; SCM03633; SCM03634; SCM03635; SCM03636; SCM03637; SCM03638; SCM03639; SCM03640; SCM03641; SCM03642; SCM03643; SCM03644; SCM03645; SCM03646; SCM03647; SCM03648; SCM03649; SCM03650; SCM03651; SCM03652; SCM03653; SCM03654; SCM03655; SCM03656; SCM03657; SCM03658; SCM03659; SCM03660; SCM03661; SCM03662; SCM03663; SCM03664; SCM03665; SCM03666; SCM03667; SCM03668; SCM03669; SCM03670; SCM03671; SCM03672; SCM03673; SCM03674; SCM03675; SCM03676; SCM03677; SCM03678; SCM03679; SCM03680; SCM03681; SCM03682; SCM03683; SCM03684; SCM03685; SCM03686; SCM03687; SCM03688; SCM03689; SCM03690; SCM03691; SCM03692; SCM03693; SCM03694; SCM03695; SCM03696; SCM03697; SCM03698; SCM03699; SCM03700; SCM03701; SCM03702; SCM03703; SCM03704; SCM03705; SCM03706; SCM03707; SCM03708; SCM03709; SCM03710; SCM03711; SCM03712; SCM03713; SCM03714; SCM03715; SCM03716; SCM03717; SCM03718; SCM03719; SCM03720; SCM03721; SCM03722; SCM03723; SCM03724; SCM03725; SCM03726; SCM03727; SCM03728; SCM03729; SCM03730; SCM03731; SCM03732; SCM03733; SCM03734; SCM03735; SCM03736; SCM03737; SCM03738; SCM03739; SCM03740; SCM03741; SCM03742; SCM03743; SCM03744; SCM03745; SCM03746; SCM03747; SCM03748; SCM03749; SCM03750; SCM03751; SCM03752; SCM03753; SCM03754; SCM03755; SCM03756; SCM03757; SCM03758; SCM03759; SCM03760; SCM03761; SCM03762; SCM03763; SCM03764; SCM03765; SCM03766; SCM03767; SCM03768; SCM03769; SCM03770; SCM03771; SCM03772; SCM03773; SCM03774; SCM03775; SCM03776; SCM03777; SCM03778; SCM03779; SCM03780; SCM03781; SCM03782; SCM03783; SCM03784; SCM03785; SCM03786; SCM03787; SCM03788; SCM03789; SCM03790; SCM03791; SCM03792; SCM03793; SCM03794; SCM03795; SCM03796; SCM03797; SCM03798; SCM03799; SCM03800; SCM03801; SCM03802; SCM03803; SCM03804; SCM03805; SCM03806; SCM03807; SCM03808; SCM03809; SCM03810; SCM03811; SCM03812; SCM03813; SCM03814; SCM03815; SCM03816; SCM03817; SCM03818; SCM03819; SCM03820; SCM03821; SCM03822; SCM03823; SCM03824; SCM03825; SCM03826; SCM03827; SCM03828; SCM03829; SCM03830; SCM03831; SCM03832; SCM03833; SCM03834; SCM03835; SCM03836; SCM03837; SCM03838; SCM03839; SCM03840; SCM03841; SCM03842; SCM03843; SCM03844; SCM03845; SCM03846; SCM03847; SCM03848; SCM03849; SCM03850; SCM03851; SCM03852; SCM03853; SCM03854; SCM03855; SCM03856; SCM03857; SCM03858; SCM03859; SCM03860; SCM03861; SCM03862; SCM03863; SCM03864; SCM03865; SCM03866; SCM03867; SCM03868; SCM03869; SCM03870; SCM03871; SCM03872; SCM03873; SCM03874; SCM03875; SCM03876; SCM03877; SCM03878; SCM03879; SCM03880; SCM03881; SCM03882; SCM03883; SCM03884; SCM03885; SCM03886; SCM03887; SCM03888; SCM03889; SCM03890; SCM03891; SCM03892; SCM03893; SCM03894; SCM03895; SCM03896; SCM03897; SCM03898; SCM03899; SCM03900; SCM03901; SCM03902; SCM03903; SCM03904; SCM03905; SCM03906; SCM03907; SCM03908; SCM03909; SCM03910; SCM03911; SCM03912; SCM03913; SCM03914; SCM03915; SCM03916; SCM03917; SCM03918; SCM03919; SCM03920; SCM03921; SCM03922; SCM03923; SCM03924; SCM03925; SCM03926; SCM03927; SCM03928; SCM03929; SCM03930; SCM03931; SCM03932; SCM03933; SCM03934; SCM03935; SCM03936; SCM03937; SCM03938; SCM03939; SCM03940; SCM03941; SCM03942; SCM03943; SCM03944; SCM03945; SCM03946; SCM03947; SCM03948; SCM03949; SCM03950; SCM03951; SCM03952; SCM03955; SCM03956; SCM03957; SCM03958; SCM03959; SCM03960; SCM03961; SCM03962; SCM03963; SCM03964; SCM03965; SCM03966; SCM03967; SCM03968; SCM03969; SCM03970; SCM03971; SCM03972; SCM03973; SCM03974; SCM03975; SCM03976; SCM03977; SCM03978; SCM03979; SCM03980; SCM03981; SCM03982; SCM03983; SCM03984; SCM03985; SCM03986; SCM03987; SCM03988; SCM03989; SCM03990; SCM03991; SCM03992; SCM03993; SCM03994; SCM03995; SCM03996; SCM03997; SCM03998; SCM03999; SCM04000; SCM04001; SCM04002; SCM04003; SCM04004; SCM04005; SCM04006; SCM04007; SCM04008; SCM04009; SCM04010; SCM04011; SCM04012; SCM04013; SCM04014; SCM04015; SCM04016; SCM04017; SCM04018; SCM04019; SCM04020; SCM04021; SCM04022; SCM04023; SCM04024; SCM04025; SCM04026; SCM04027; SCM04028; SCM04029; SCM04030; SCM04031; SCM04032; SCM04033; SCM04034; SCM04035; SCM04036; SCM04037; SCM04038; SCM04039; SCM04040; SCM04041; SCM04042; SCM04043; SCM04044; SCM04045; SCM04046; SCM04047; SCM04048; SCM04049; SCM04050; SCM04051; SCM04052; SCM04053; SCM04054; SCM04055; SCM04056; SCM04057; SCM04058; SCM04059; SCM04060; SCM04061; SCM04062; SCM04063; SCM04064; SCM04065; SCM04066; SCM04067; SCM04068; SCM04069; SCM04070; SCM04071; SCM04072; SCM04073; SCM04074; SCM04075; SCM04076; SCM04077; SCM04078; SCM04079; SCM04080; SCM04081; SCM04082; SCM04083; SCM04084; SCM04085; SCM04086; SCM04087; SCM04088; SCM04089; SCM04090; SCM04091; SCM04092; SCM04093; SCM04094; SCM04095; SCM04096; SCM04097; SCM04098; SCM04099; SCM04100; SCM04101; SCM04102; SCM04103; SCM04104; SCM04105; SCM04106; SCM04107; SCM04108; SCM04109; SCM04110; SCM04111; SCM04112; SCM04113; SCM04114; SCM04115; SCM04116; SCM04117; SCM04118; SCM04119; SCM04120; SCM04121; SCM04122; SCM04123; SCM04124; SCM04125; SCM04126; SCM04127; SCM04128; SCM04129; SCM04130; SCM04131; SCM04132; SCM04133; SCM04134; SCM04135; SCM04136; SCM04137; SCM04138; SCM04139; SCM04140; SCM04141; SCM04142; SCM04143; SCM04144; SCM04145; SCM04146; SCM04147; SCM04148; SCM04149; SCM04150; SCM04151; SCM04152; SCM04153; SCM04154; SCM04155; SCM04156; SCM04157; SCM04158; SCM04159; SCM04160; SCM04161; SCM04162; SCM04163; SCM04164; SCM04165; SCM04166; SCM04167; SCM04168; SCM04169; SCM04170; SCM04171; SCM04172; SCM04173; SCM04174; SCM04175; SCM04176; SCM04177; SCM04178; SCM04179; SCM04180; SCM04181; SCM04182; SCM04183; SCM04184; SCM04185; SCM04186; SCM04187; SCM04188; SCM04189; SCM04190; SCM04191; SCM04192; SCM04193; SCM04194; SCM04195; SCM04196; SCM04197; SCM04198; SCM04199; SCM04200; SCM04201; SCM04202; SCM04203; SCM04204; SCM04205; SCM04206; SCM04207; SCM04208; SCM04209; SCM04210; SCM04211; SCM04212; SCM04213; SCM04214; SCM04215; SCM04216; SCM04217; SCM04218; SCM04219; SCM04220; SCM04221; SCM04222; SCM04223; SCM04224; SCM04225; SCM04226; SCM04227; SCM04228; SCM04229; SCM04230; SCM04231; SCM04232; SCM04233; SCM04234; SCM04235; SCM04236; SCM04237; SCM04238; SCM04239; SCM04240; SCM04241; SCM04242; SCM04243; SCM04244; SCM04245; SCM04246; SCM04247; SCM04248; SCM04249; SCM04250; SCM04251; SCM04252; SCM04253; SCM04254; SCM04255; SCM04256; SCM04257; SCM04258; SCM04259

Quantity Affected: 4,833 systems

Reason for Recall

Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-07-26

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