Class II FDA device recall · Z-3122-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm: BioFire Diagnostics, LLC
Product type: Devices
Recall number: Z-3122-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Salt Lake City, UT
Recall initiated: 2024-08-07

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-3122-2024 · Source: openFDA enforcement.