Summary
The FDA issued a Class II for Alinity hq Analyzer, REF: 09P68-01 by Abbott Laboratories. Reason: 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is.
Details
Source
Device Recall
External ID
Z-2681-2024
Action Date
2024-08-28
Status
Ongoing
Category
device
Product Description
Alinity hq Analyzer, REF: 09P68-01
Lot/Code Info: UDI-DI: 380740138851. Software Versions: 5.7 (US) and 5.6 and below (OUS), Serial Numbers: HQ00105, HQ00108, HQ00117, HQ00118, HQ00119, HQ00120, HQ00126, HQ00127, HQ00128, HQ00132, HQ00136, HQ00139, HQ00140, HQ00141, HQ00142, HQ00144, HQ00145, HQ00147, HQ00148, HQ00149, HQ00152, HQ00153, HQ00154, HQ00156, HQ00157, HQ00161, HQ00162, HQ00166, HQ00169, HQ00171, HQ00172, HQ00173, HQ00174, HQ00175, HQ00183, HQ00184, HQ00185, HQ00186, HQ00187, HQ00188, HQ00266, HQ00268, HQ00269, HQ00270, HQ00271, HQ00273, HQ00274, HQ00276, HQ00277, HQ00278, HQ00279, HQ00281, HQ00282, HQ00283, HQ00286, HQ00287, HQ00289, HQ00291, HQ00295, HQ00296, HQ00299, HQ00300, HQ00302, HQ00303, HQ00312, HQ00313, HQ00314, HQ00316, HQ00318, HQ00319, HQ00321, HQ00324, HQ00327, HQ00328, HQ00329, HQ00331, HQ00332, HQ00334, HQ00335, HQ00336, HQ00337, HQ00338, HQ00417, HQ00418, HQ00419, HQ00420, HQ00422, HQ00424, HQ00425, HQ00430, HQ00432, HQ00433, HQ00434, HQ00435, HQ00436, HQ00438, HQ00439, HQ00440, HQ00441, HQ00442, HQ00443, HQ00444, HQ00445, HQ00446, HQ00447, HQ00448, HQ00451, HQ00453, HQ00455, HQ00456, HQ00457, HQ00458, HQ00460, HQ00461, HQ00463, HQ00464, HQ00466, HQ00468, HQ00469, HQ00471, HQ00472, HQ00474, HQ00475, HQ00476, HQ00536, HQ00539, HQ00540, HQ00541, HQ00542, HQ00544, HQ00545, HQ00546, HQ00547, HQ00548, HQ00550, HQ00551, HQ00552, HQ00553, HQ00554, HQ00555, HQ00558, HQ00561, HQ00562, HQ00563, HQ00564, HQ00565, HQ00567, HQ00568, HQ00569, HQ00570, HQ00571, HQ00573, HQ00574, HQ00575, HQ00576, HQ00577, HQ00578, HQ00579, HQ00580, HQ00581, HQ00582, HQ00583, HQ00584, HQ00585, HQ00586, HQ00587, HQ00638, HQ00639, HQ00640, HQ00641, HQ00642, HQ00643, HQ00644, HQ00645, HQ00646, HQ00647, HQ00648, HQ00649, HQ00650, HQ00651, HQ00654, HQ00655, HQ00657, HQ00660, HQ00662, HQ00663, HQ00665, HQ00666, HQ00667, HQ00668, HQ00669, HQ00670, HQ00671, HQ00672, HQ00673, HQ00674, HQ00675, HQ00676, HQ00677, HQ00678, HQ00679, HQ00680, HQ00681, HQ00682, HQ00683, HQ00684, HQ00685, HQ00686, HQ00731, HQ00732, HQ00733, HQ00734, HQ00735, HQ00736, HQ00737, HQ00738, HQ00740, HQ00741, HQ00742, HQ00743, HQ00744, HQ00745, HQ00746, HQ00747, HQ00748, HQ00749, HQ00750, HQ00751, HQ00753, HQ00754, HQ00756, HQ00757, HQ00758, HQ00759, HQ00760, HQ00761, HQ00762, HQ00763, HQ00764, HQ00765, HQ00766, HQ00767, HQ00768, HQ00769, HQ00770, HQ00771, HQ00772, HQ00773, HQ00774, HQ00775, HQ00819, HQ00820, HQ00821, HQ00822, HQ00823, HQ00824, HQ00825, HQ00826, HQ00827, HQ00828, HQ00829, HQ00830, HQ00831, HQ00832, HQ00833, HQ00834, HQ00835, HQ00836, HQ00837, HQ00838, HQ00839, HQ00840, HQ00841, HQ00842, HQ00844, HQ00845, HQ00846, HQ00847, HQ00848, HQ00849, HQ00852, HQ00853, HQ00856, HQ00857, HQ00858, HQ00859, HQ00860, HQ00861, HQ00864, HQ00865, HQ00866, HQ00867, HQ00923, HQ00924, HQ00925, HQ00926, HQ00927, HQ00929, HQ00932, HQ00933, HQ00934, HQ00935, HQ00936, HQ00937, HQ00938, HQ00939, HQ00940, HQ00941, HQ00942, HQ00943, HQ00944, HQ00945, HQ00946, HQ00947, HQ00949, HQ00950, HQ00951, HQ00952, HQ00953, HQ00954, HQ00955, HQ00956, HQ00957, HQ00958, HQ00959, HQ00960, HQ00961, HQ00962, HQ00963, HQ00964, HQ00965, HQ00966, HQ00967, HQ00968, HQ01018, HQ01019, HQ01020, HQ01021, HQ01022, HQ01023, HQ01024, HQ01025, HQ01026, HQ01027, HQ01028, HQ01029, HQ01030, HQ01031, HQ01032, HQ01033, HQ01034, HQ01035, HQ01037, HQ01038, HQ01039, HQ01040, HQ01043, HQ01044, HQ01046, HQ01047, HQ01049, HQ01050, HQ01051, HQ01052, HQ01054, HQ01055, HQ01056, HQ01057, HQ01058, HQ01060, HQ01061, HQ01062, HQ01063, HQ01064, HQ01065, HQ01067, HQ01122, HQ01123, HQ01124, HQ01125, HQ01126, HQ01127, HQ01128, HQ01129, HQ01130, HQ01131, HQ01132, HQ01133, HQ01134, HQ01135, HQ01136, HQ01137, HQ01138, HQ01139, HQ01140, HQ01141, HQ01142, HQ01143, HQ01144, HQ01145, HQ01146, HQ01147, HQ01148, HQ01149, HQ01150, HQ01151, HQ01152, HQ01153, HQ00191, HQ00192, HQ00193, HQ00194, HQ00196, HQ00197, HQ00198, HQ00201, HQ00202, HQ00203, HQ00204, HQ00208, HQ00209, HQ00210, HQ00214, HQ00215, HQ00217, HQ00218, HQ00222, HQ00223, HQ00230, HQ00231, HQ00233, HQ00242, HQ00243, HQ00244, HQ00245, HQ00246, HQ00248, HQ00250, HQ00252, HQ00254, HQ00255, HQ00257, HQ00258, HQ00259, HQ00260, HQ00261, HQ00264, HQ00265, HQ00343, HQ00344, HQ00346, HQ00347, HQ00348, HQ00349, HQ00350, HQ00352, HQ00353, HQ00356, HQ00357, HQ00358, HQ00359, HQ00361, HQ00362, HQ00364, HQ00365, HQ00368, HQ00371, HQ00372, HQ00376, HQ00378, HQ00379, HQ00380, HQ00382, HQ00383, HQ00384, HQ00385, HQ00386, HQ00387, HQ00389, HQ00390, HQ00391, HQ00393, HQ00404, HQ00406, HQ00410, HQ00411, HQ00413, HQ00414, HQ00415, HQ00416, HQ00477, HQ00478, HQ00479, HQ00481, HQ00483, HQ00484, HQ00485, HQ00487, HQ00489, HQ00490, HQ00491, HQ00492, HQ00493, HQ00494, HQ00495, HQ00496, HQ00497, HQ00498, HQ00499, HQ00500, HQ00501, HQ00503, HQ00504, HQ00505, HQ00506, HQ00507, HQ00508, HQ00509, HQ00510, HQ00511, HQ00512, HQ00513, HQ00514, HQ00516, HQ00517, HQ00519, HQ00524, HQ00527, HQ00528, HQ00530, HQ00534, HQ00535, HQ00588, HQ00589, HQ00590, HQ00591, HQ00592, HQ00593, HQ00594, HQ00595, HQ00596, HQ00598, HQ00599, HQ00600, HQ00601, HQ00602, HQ00603, HQ00604, HQ00605, HQ00606, HQ00607, HQ00608, HQ00609, HQ00610, HQ00611, HQ00612, HQ00613, HQ00614, HQ00615, HQ00616, HQ00620, HQ00623, HQ00625, HQ00626, HQ00627, HQ00628, HQ00629, HQ00630, HQ00631, HQ00632, HQ00633, HQ00634, HQ00635, HQ00637, HQ00687, HQ00688, HQ00689, HQ00690, HQ00691, HQ00692, HQ00693, HQ00694, HQ00695, HQ00696, HQ00697, HQ00698, HQ00699, HQ00700, HQ00701, HQ00703, HQ00704, HQ00705, HQ00706, HQ00707, HQ00708, HQ00709, HQ00710, HQ00711, HQ00712, HQ00713, HQ00715, HQ00716, HQ00717, HQ00718, HQ00719, HQ00720, HQ00721, HQ00722, HQ00723, HQ00724, HQ00725, HQ00726, HQ00727, HQ00728, HQ00729, HQ00730, HQ00776, HQ00777, HQ00778, HQ00779, HQ00780, HQ00781, HQ00782, HQ00783, HQ00785, HQ00786, HQ00787, HQ00788, HQ00789, HQ00790, HQ00791, HQ00792, HQ00793, HQ00794, HQ00795, HQ00796, HQ00797, HQ00798, HQ00799, HQ00800, HQ00801, HQ00802, HQ00803, HQ00804, HQ00805, HQ00806, HQ00807, HQ00808, HQ00809, HQ00810, HQ00811, HQ00812, HQ00813, HQ00814, HQ00815, HQ00816, HQ00817, HQ00818, HQ00868, HQ00870, HQ00871, HQ00873, HQ00874, HQ00875, HQ00876, HQ00879, HQ00880, HQ00881, HQ00882, HQ00883, HQ00885, HQ00887, HQ00888, HQ00890, HQ00891, HQ00892, HQ00893, HQ00894, HQ00895, HQ00896, HQ00899, HQ00900, HQ00901, HQ00902, HQ00903, HQ00904, HQ00905, HQ00906, HQ00907, HQ00911, HQ00913, HQ00914, HQ00915, HQ00916, HQ00917, HQ00918, HQ00919, HQ00920, HQ00921, HQ00922, HQ00969, HQ00970, HQ00971, HQ00972, HQ00973, HQ00974, HQ00975, HQ00976, HQ00977, HQ00978, HQ00979, HQ00980, HQ00981, HQ00982, HQ00983, HQ00984, HQ00985, HQ00986, HQ00987, HQ00989, HQ00990, HQ00991, HQ00994, HQ00995, HQ00996, HQ00997, HQ00998, HQ00999, HQ01000, HQ01001, HQ01002, HQ01003, HQ01006, HQ01007, HQ01008, HQ01009, HQ01011, HQ01013, HQ01014, HQ01015, HQ01016, HQ01017, HQ01068, HQ01069, HQ01070, HQ01071, HQ01072, HQ01073, HQ01074, HQ01075, HQ01076, HQ01077, HQ01078, HQ01079, HQ01080, HQ01081, HQ01082, HQ01083, HQ01084, HQ01085, HQ01086, HQ01087, HQ01088, HQ01089, HQ01091, HQ01092, HQ01093, HQ01094, HQ01095, HQ01096, HQ01097, HQ01098, HQ01102, HQ01103, HQ01104, HQ01105, HQ01108, HQ01113, HQ01114, HQ01116, HQ01118, HQ01119, HQ01120, HQ01121, HQ01155, HQ01156, HQ01157, HQ01158, HQ01159, HQ01160, HQ01161, HQ01162, HQ01165, HQ01167, HQ01168, HQ01169, HQ01170, HQ01171, HQ01172, HQ01173, HQ01174, HQ01175, HQ01177, HQ01180, HQ01181, HQ01183, HQ01187, HQ01188, HQ01190, HQ01196, HQ01231, HQ01233, HQ01236, HQ01237, HQ01244, HQ01246
Quantity Affected: 816
Reason for Recall
1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
Distribution
Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, VIETNAM.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-14
Company
Santa Clara, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2681-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29