BioFire Diagnostics, LLC: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

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.

Details from the source

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: 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, Jap Quantity: 3,439 Lot/code info: HTFA-ASY-0003, UDI: 00815381020277, Serial Numbers: KTM01040, KTM03252, KTM05330, KTM05411, KTM05602, KTM05734, KTM05800, KTM05810, KTM05887, KTM05997, KTM06000, KTM06003, KTM06005, KTM06038, KTM06057, KTM06063, KTM06139, KTM06639, KTM06756, KTM06870, KTM06902, KTM07116, KTM13705, KTM13710, KTM13815, KTM14196, KTM14329, KTM14357, KTM14918, KTM15242, KTM15798, KTM15801, KTM15819, KTM17194, KTM17531, KTM17570, KTM17576, KTM17696, KTM17812, KTM18083, KTM18448, KTM18453, KTM18464, KTM18559, KTM19173, KTM19183, KTM19386, KTM20255, KTM20260, KTM20273, KTM20280, KTM20296, KTM20299, KTM20301, KTM20308, KTM20314, KTM20318, KTM20321, KTM20324, KTM20325, KTM20330, KTM20354, KTM20398, KTM20403, KTM20502, KTM13752, KTM18382, KTM19197, KTM19634, KTM19610, KTM20269, KTM21459, KTM00143, KTM00173, KTM00221, KTM00230, KTM00237, KTM01401, KTM01437, KTM01439, KTM01446, KTM00247, KTM07097, KTM07224, KTM07422, KTM09682, KTM10535, KTM10550, KTM12833, KTM13438, KTM14845, KTM18045, KTM15398, KTM01947, KTM04128, KTM05500, KTM05501, KTM06798, KTM06929, KTM08608, KTM08780, KTM08830, KTM08977, KTM10092, KTM10527, KTM11388, KTM11583, KTM11617, KTM11624, KTM11687, KTM12214, KTM12456, KTM12622, KTM12637, KTM13777, KTM13784, KTM14421, KTM14536, KTM15336, KTM15984, KTM16048, KTM16148, KTM16426, KTM16708, KTM16729, KTM17030, KTM17237, KTM17427, KTM20259, KTM20262, KTM20272, KTM20281, KTM20287, KTM20291, KTM20295, KTM20306, KTM20311, KTM20313, KTM20317, KTM20326, KTM20339, KTM20340, KTM20357, KTM17378, KTM20242

UPC codes

00815381020277, 00815381029089

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.