FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Summary

The FDA issued a Class II for FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W by BioFire Diagnostics, LLC. Reason: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipm.

Details

Product Description

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Lot/Code Info: FLM2-ASY-0001, UDI: 00815381020031, Serial Numbers: 2FA00610, 2FA00951, 2FA00964, 2FA01005, 2FA01115, 2FA01116, 2FA01128, 2FA01418, 2FA01653, 2FA01733, 2FA01771, 2FA01775, 2FA01878, 2FA02805, 2FA02977, 2FA02981, 2FA03194, 2FA03196, 2FA03237, 2FA03273, 2FA03303, 2FA03335, 2FA03343, 2FA06079, 2FA06473, 2FA07884, 2FA07987, 2FA07996, 2FA08386, 2FA01224, 2FAD848B, 2FA00229, 2FA00386, 2FA00396, 2FA00551, 2FA00558, 2FA01693, 2FA02188, 2FA02296, 2FA02347, 2FA02422, 2FA05086, 2FA05089, 2FA05099, 2FA05172, 2FA05186, 2FA05256, 2FA05273, 2FA05287, 2FA05300, 2FA05601, 2FA06055, 2FA06140, 2FA06236, 2FA06297, 2FA06655, 2FA06867, 2FA07093, 2FA07173, 2FA07175, 2FA07194, 2FA07260, 2FA07312, 2FA07728, 2FA07848, 2FA07849, 2FA07856, 2FA07859, 2FA07860, 2FA07867, 2FA07870, 2FA07892, 2FA07916, 2FA07933, 2FA07976, 2FA07978, 2FA08054, 2FA08145, 2FA08336, 2FA08559, 2FA08579, 2FA08700, 2FA08728, 2FA08785, 2FA09867, FA2461, FA2464, FA2893, FA3170, FA3566, 2FA09893, 2FA00673, 2FA00983, 2FA01178, 2FA01250, 2FA02300, 2FA02823, 2FA03096, 2FA03115, 2FA03119, 2FA03133, 2FA03490, 2FA05263, 2FA05602, 2FA05950, 2FA06200, 2FA06274, 2FA06484, 2FA06645, 2FA07047, 2FA07253, 2FA07334, 2FA07388, 2FA07445, 2FA07446, 2FA07452, 2FA07471, 2FA07488, 2FA07682, 2FA07705, 2FA06431, 2FA09166, 2FAA364A, 2FAB4CAC, 2FAE02D5, 2FA08587, 2FA07899, 2FA01903, 2FA02860, 2FA05962, 2FA06659, 2FA06740, 2FA06746, 2FA06811, 2FA06905, 2FA06912, 2FA06954, 2FA06955, 2FA07084, 2FA07222, 2FA07225, 2FA07267, 2FA07350, 2FA07423, 2FA07450, 2FA07603, 2FA07812, 2FA07822, 2FA07964, 2FA08017, 2FA08045, 2FA08188, 2FA2AD2E, 2FA3331D, 2FAC0903, 2FA03026, 2FA05845, 2FA06670, 2FA06724, 2FA07795, 2FA08558, 2FA08782, 2FA09350, 2FA09371, 2FA09376. FLM2-ASY-0001-W, UDI: 00815381029058, Serial Numbers: 2FA00046, 2FA00049, 2FA00050, 2FA00053, 2FA00060, 2FA00066, 2FA00076, 2FA00079, 2FA00090, 2FA00093, 2FA00116, 2FA00117, 2FA00131, 2FA00139, 2FA00142, 2FA00150, 2FA00157, 2FA00159, 2FA00167, 2FA00169, 2FA00172, 2FA00174, 2FA00176, 2FA00185, 2FA00186, 2FA00187, 2FA00209, 2FA00210, 2FA00217, 2FA00220, 2FA00221, 2FA00275, 2FA00278, 2FA00295, 2FA00298, 2FA00299, 2FA00308, 2FA00333, 2FA00340, 2FA00343, 2FA00344, 2FA00346, 2FA00348, 2FA00359, 2FA00360, 2FA00365, 2FA00366, 2FA00369, 2FA00372, 2FA00378, 2FA00390, 2FA00403, 2FA00405, 2FA00413, 2FA00415, 2FA00424, 2FA00435, 2FA00436, 2FA00440, 2FA00442, 2FA00452, 2FA00453, 2FA00455, 2FA00456, 2FA00459, 2FA00483, 2FA00498, 2FA00500, 2FA00521, 2FA00529, 2FA00540, 2FA00542, 2FA00543, 2FA00544, 2FA00561, 2FA00570, 2FA00582, 2FA00611, 2FA00618, 2FA00620, 2FA00633, 2FA00658, 2FA00676, 2FA00678, 2FA00682, 2FA00684, 2FA00692, 2FA00695, 2FA00715, 2FA00716, 2FA00731, 2FA00738, 2FA00760, 2FA00795, 2FA00813, 2FA00838, 2FA00842, 2FA00847, 2FA00864, 2FA00881, 2FA00882, 2FA00886, 2FA00887, 2FA00893, 2FA00904, 2FA00908, 2FA00909, 2FA00922, 2FA00942, 2FA00948, 2FA00952, 2FA00960, 2FA00965, 2FA00970, 2FA00971, 2FA00980, 2FA00984, 2FA01001, 2FA01028, 2FA01035, 2FA01041, 2FA01043, 2FA01047, 2FA01051, 2FA01056, 2FA01068, 2FA01088, 2FA01106, 2FA01121, 2FA01122, 2FA01133, 2FA01151, 2FA01155, 2FA01168, 2FA01175, 2FA01216, 2FA01226, 2FA01230, 2FA01232, 2FA01233, 2FA01242, 2FA01259, 2FA01270, 2FA01274, 2FA01275, 2FA01288, 2FA01290, 2FA01292, 2FA01294, 2FA01302, 2FA01312, 2FA01325, 2FA01335, 2FA01336, 2FA01344, 2FA01351, 2FA01358, 2FA01366, 2FA01370, 2FA01378, 2FA01380, 2FA01389, 2FA01390, 2FA01393, 2FA01408, 2FA01419, 2FA01429, 2FA01435, 2FA01444, 2FA01449, 2FA01462, 2FA01471, 2FA01473, 2FA01476, 2FA01491, 2FA01520, 2FA01543, 2FA01555, 2FA01559, 2FA01568, 2FA01571, 2FA01574, 2FA01579, 2FA01605, 2FA01612, 2FA01650, 2FA01651, 2FA01670, 2FA01688, 2FA01731, 2FA01740, 2FA01748, 2FA01787, 2FA01804, 2FA01810, 2FA01814, 2FA01820, 2FA01824, 2FA01847, 2FA01858, 2FA01860, 2FA01876, 2FA01888, 2FA01929, 2FA01932, 2FA02005, 2FA02006, 2FA02009, 2FA02015, 2FA02018, 2FA02023, 2FA02029, 2FA02033, 2FA02035, 2FA02040, 2FA02086, 2FA02098, 2FA02110, 2FA02125, 2FA02134, 2FA02140, 2FA02147, 2FA02199, 2FA02201, 2FA02233, 2FA02241, 2FA02249, 2FA02295, 2FA02330, 2FA02343, 2FA02359, 2FA02380, 2FA02383, 2FA02401, 2FA02407, 2FA02468, 2FA02473, 2FA02479, 2FA02500, 2FA02519, 2FA02537, 2FA02550, 2FA02555, 2FA02571, 2FA02574, 2FA02600, 2FA02611, 2FA02647, 2FA02656, 2FA02677, 2FA02683, 2FA02690, 2FA02694, 2FA02712, 2FA02719, 2FA02721, 2FA02727, 2FA02731, 2FA02732, 2FA02742, 2FA02747, 2FA02758, 2FA02764, 2FA02765, 2FA02774, 2FA02782, 2FA02784, 2FA02786, 2FA02787, 2FA02790, 2FA02794, 2FA02803, 2FA02817, 2FA02855, 2FA02876, 2FA02877, 2FA02883, 2FA02885, 2FA02905, 2FA02967, 2FA02987, 2FA02988, 2FA03013, 2FA03035, 2FA03037, 2FA03045, 2FA03085, 2FA03109, 2FA03147, 2FA03149, 2FA03152, 2FA03163, 2FA03171, 2FA03173, 2FA03179, 2FA03201, 2FA03202, 2FA03217, 2FA03234, 2FA03277, 2FA03280, 2FA03289, 2FA03295, 2FA03308, 2FA03309, 2FA03312, 2FA03321, 2FA03324, 2FA03330, 2FA03332, 2FA03346, 2FA03349, 2FA03353, 2FA03371, 2FA03419, 2FA03422, 2FA03435, 2FA03441, 2FA03445, 2FA03456, 2FA03476, 2FA05008, 2FA05018, 2FA05036, 2FA05051, 2FA05068, 2FA05091, 2FA05134, 2FA05228, 2FA05371, 2FA05372, 2FA05398, 2FA05399, 2FA05415, 2FA05436, 2FA05460, 2FA05470, 2FA05480, 2FA05488, 2FA05498, 2FA05499, 2FA05507, 2FA05549, 2FA05552, 2FA05554, 2FA05570, 2FA05581, 2FA05615, 2FA05634, 2FA05719, 2FA05731, 2FA05741, 2FA05756, 2FA05825, 2FA05892, 2FA05923, 2FA05932, 2FA05983, 2FA06011, 2FA06016, 2FA06022, 2FA06051, 2FA06099, 2FA06103, 2FA06220, 2FA06231, 2FA06267, 2FA06465, 2FA06512, 2FA06566, 2FA06586, 2FA06643, 2FA06663, 2FA06683, 2FA06687, 2FA06690, 2FA06695, 2FA06731, 2FA06752, 2FA06759, 2FA06876, 2FA06888, 2FA06894, 2FA06895, 2FA06901, 2FA06917, 2FA06923, 2FA06925, 2FA06933, 2FA06938, 2FA06964, 2FA06980, 2FA06991, 2FA07146, 2FA07152, 2FA07289, 2FA07492, 2FA07521, 2FA07605, 2FA07661, 2FA07686, 2FA07753, 2FA07780, 2FA07791, 2FA07801, 2FA07813, 2FA07838, 2FA07912, 2FA07927, 2FA07946, 2FA07949, 2FA07957, 2FA07986, 2FA07991, 2FA08008, 2FA08012, 2FA08020, 2FA08025, 2FA08039, 2FA08043, 2FA08059, 2FA08220, 2FA08233, 2FA08244, 2FA08253, 2FA08363, 2FA08425, 2FA08431, 2FA08715, 2FA08751, 2FA08829, 2FA08893, 2FA09016, 2FA09074, 2FA09130, 2FA09372, 2FA09414, 2FA09775, 2FA09829, 2FA09836, 2FA0C61F, 2FA0D44D, 2FA162B8, 2FA1AD7D, 2FA1DE96, 2FA1E2AB, 2FA2BF60, 2FA30B8B, 2FA4648F, 2FA60A82, 2FA67D12, 2FA68462, 2FA68A67, 2FA6B84F, 2FA6EA3B, 2FA81DA9, 2FA8C329, 2FA8E4EF, 2FA94FAE, 2FA9E3D0, 2FAA2D5A, 2FAA95D1, 2FAA9A2E, 2FAAE506, 2FAB0ADB, 2FAB707D, 2FABFA37, 2FAC832F, 2FAD5CA4, 2FADECBC, 2FADF2E2, 2FAECD37, 2FAED036, 2FAEE1C1, 2FAEF934, 2FAF79F0, 2FAFB3EE, 2FAFD14C, 2FAFDD78, FA1131, FA1157, FA1162, FA1192, FA1231, FA1240, FA1242, FA1275, FA1322, FA1331, FA1350, FA1351, FA2009, FA2011, FA2036, FA2107, FA2120, FA2124, FA2126, FA2127, FA2150, FA2154, FA2194, FA2199, FA2212, FA2219, FA2265, FA2266, FA2343, FA2367, FA2525, FA2552, FA2559, FA2568, FA2569, FA2580, FA2582, FA2589, FA2602, FA2631, FA2669, FA2679, FA2682, FA2694, FA2711, FA2721, FA2773, FA2775, FA2786, FA2790, FA2795, FA2822, FA2828, FA2838, FA2842, FA2851, FA2871, FA2876, FA2878, FA2902, FA2910, FA2960, FA2962, FA2963, FA2964, FA2987, FA2994, FA3006, FA3013, FA3025, FA3062, FA3071, FA3104, FA3118, FA3121, FA3132, FA3196, FA3201, FA3203, FA3204, FA3209, FA3224, FA3343, FA3347, FA3362, FA3370, FA3385, FA3386, FA3391, FA3392, FA3463, FA3472, FA3489, FA3498, FA3503, FA3506, FA3515, FA3522, FA3526, FA3528, FA3587, FA3604, FA3607, FA3611, FA3623, FA3633, FA3636, FA3665, FA3669, FA3675, FA3678, FA3686, FA3687, FA3689, FA3732, FA3735, FA3752, FA3790, FA3822, FA3827, FA3828, FA3869, FA3875, FA3878, FA3895, FA3915, FA3945, FA3953, FA3954, FA5009, FA5021, FA5025, FA5046, FA5087, FA5089, FA5107, FA5124, FA5128, 2FA03351, 2FA00330, 2FA01405, FA2590, FA3520, FA3582, 2FA01021, FA3551, 2FA01585, 2FA02255, 2FAE7C9F, FA1137, FA4032, 2FA00546, 2FA02466, 2FA03329, 2FA03485, 2FA05173, 2FA06261, 2FA08494, 2FA7523A, FA2895, FA3168, FA3236, FA3852, 2FA00465, 2FA00507, 2FA00768, 2FA00920, 2FA01182, 2FA01210, 2FA01271, 2FA01394, 2FA01545, 2FA01548, 2FA01797, 2FA01883, 2FA02085, 2FA97804, 2FA02713, 2FA02889, 2FA02914, 2FA02958, 2FA02962, 2FA03040, 2FA03178, 2FA03238, 2FA03248, 2FA03267, 2FA03275, 2FA03370, 2FA03390, 2FA05206, 2FA05258, 2FA05291, 2FA05321, 2FA05324, 2FA05349, 2FA05353, 2FA05374, 2FA05502, 2FA05726, 2FA05802, 2FA05808, 2FA05868, 2FA05893, 2FA05894, 2FA05896, 2FA05931, 2FA05990, 2FA06097, 2FA06182, 2FA06394, 2FA10B0F, 2FA06432, 2FA06471, 2FA06476, 2FA06488, 2FA06553, 2FA06625, 2FA06640, 2FA06658, 2FA06700, 2FA06920, 2FA06947, 2FA07075, 2FA07258, 2FA07296, 2FA07346, 2FA06462, 2FA07498, 2FA07510, 2FA07514, 2FA07518, 2FA07526, 2FA07587, 2FA07615, 2FA07662, 2FA07906, 2FA08007, 2FA08026, 2FA08064, 2FA08093, 2FA08102, 2FA08118, 2FA08355, 2FA08368, 2FA08394, 2FA08557, 2FA09046, 2FA1409B, 2FA41764, 2FA42B8C, 2FA673DA, 2FA6E384, 2FA72444, 2FA72DE6, 2FA8006F, 2FA9A735, 2FAA418F, 2FAA6C04, 2FAA9A48, 2FAA9D59, 2FAB6196, 2FAB6E1E, 2FACA9FB, 2FAFA330, FA1266, FA2137, FA3205, FA3697, FA4089, 2FA02512, 2FA05072, 2FA01076, 2FAC5C3D, 2FA06675, 2FA00325, 2FA01180, 2FA01781, 2FA01926, 2FA02292, 2FA02448, 2FA02701, 2FA02849, 2FA02960, 2FA05250, 2FA05496, 2FA05729, 2FA05830, 2FA05891, 2FA05912, 2FA05933, 2FA05948, 2FA06012, 2FA06023, 2FA06042, 2FA06150, 2FA06285, 2FA06288, 2FA06289, 2FA06290, 2FA06291, 2FA06493, 2FA06513, 2FA06562, 2FA06567, 2FA06641, 2FA07220, 2FA07269, 2FA07482, 2FA08626, 2FA08890, 2FA09084, 2FA09129, 2FA09154, 2FA09277, 2FA09290, 2FA09936, 2FA10137, 2FA26D4C, 2FA39CFB, 2FA3E685, 2FA46A79, 2FA49D78, 2FA4D8D7, 2FA5A2EF, 2FA72E4F, 2FA74CFA, 2FA770A3, 2FAA0968, 2FAD9D4B, 2FADA123, 2FAF0FAE, FA2131, 2FA01877, 2FA07144, 2FA01541, 2FA06672, 2FA08150, 2FA01179, 2FA03219, 2FA491E9, 2FA12FC8, FA3684, 2FA06598, 2FA02698, 2FA03025, 2FA05209, 2FA05633, 2FA06072, 2FA06496, 2FA06732, 2FA07256, 2FA07992, FA2680, FA3000, FA3303, 2FA02872

Quantity Affected: 1001

Reason for Recall

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-08-07

Company