FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
FDA Device Recall #Z-3122-2024 — Class II — August 7, 2024
Recall Summary
| Recall Number | Z-3122-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 7, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BioFire Diagnostics, LLC |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 1001 |
Product Description
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
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.
Distribution Pattern
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.
Lot / Code Information
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
Other Recalls from BioFire Diagnostics, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0602-2026 | Class II | BioFire Respiratory Panel 2.1, IVD, REF: 423742... | Oct 22, 2025 |
| Z-1877-2025 | Class II | BioFire Respiratory Panel 2.1 plus Kit, REF: 42... | Apr 30, 2025 |
| Z-1518-2025 | Class II | FilmArra Pneumonia Panel plus (Pneumoplus), REF... | Feb 27, 2025 |
| Z-3123-2024 | Class II | FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA... | Aug 7, 2024 |
| Z-2456-2024 | Class II | BIOFIRE Blood Culture Identification 2 (BCID2) ... | Jun 19, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.