FDAFDA · Food and drugs·Recall number Z-3122-2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Published September 18, 2024 · Recall initiated: August 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- 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
- 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, 2FA
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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