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FilmArray 2.0 Instrument recallZ-3122-2024 · BioFire Diagnostics, LLC · initiated Aug 7, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 8/7/24 Biomerieux sent recall notices to customers who were asked to do the following: 1) Utilize http://biofiredx.com/fsca5788-1/ to determine which of your instruments are impacted. 2) If your instrument is on the impacted list, it needs to be returned to the firm's Service Center for recalibration; your local contact will reach out to you to coordinate instrument return. 3) Continue to use all your instruments in accordance with product labeling (instructions for use) while waiting for service. 4) For BIOFIRE GI Panel Users, you may continue using the product as directed in the package insert, but if a positive Salmonella or Giardia lamblia result is inconsistent with clinical presentation, consider confirming the positive using another method or rerun the sample on an unaffected instrument. In patients suspected of Norovirus infection, please consider confirming Norovirus results via another method prior to reporting those results or rerun the sample on an unaffected instrument. 5) For BCID2 users, you may continue using the product as directed in the package insert; however, in patients with a Staphylococcus aureus detected result on the BCID2 panel AND suspected of a MRSA infection, please confirm all negative MRSA results via another method prior to reporting or rerun the sample on an unaffected instrument. 6) For RP2.1, RP2.1plus, ME, PN, PNplus and JI users, you may continue using the product as directed in the package insert; No confirmation of results are required. 7) If you have further distributed impacted instrument(s), identify any recipients and notify them at once by sending them a copy of the recall notice and acknowledgement form. 8) Complete all fields of the accompanying Acknowledgment of Receipt Form via email and return to [email protected] or the form can be filled out electronically by following URL: https://www.biofiredx.com/recall5788-1/ Customers with questions can contact Technical Support at biofiresupport@biomer

Recall details

Recall number
Z-3122-2024
Status
Open, Classified
Initiated by the company
Aug 7, 2024
Posted by the FDA
Sep 11, 2024
Recalling firm
BioFire Diagnostics, LLC
Quantity
1001
Product code
NSU
FDA submissions
K143178
Distribution
Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95019).

Sources and updates

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