FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

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

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, KTM03150, KTM20239, KTM20240, KTM20245, KTM20305, KTM02088, KTM20352, KTM18296, KTM04024, KTM04291, KTM04336, KTM04339, KTM15727, KTM01193, KTM03483, KTM03828, KTM03835, KTM03837, KTM04108, KTM05011, KTM05574, KTM05641, KTM05686, KTM06842, KTM06847, KTM06882, KTM07019, KTM07039, KTM07088, KTM07093, KTM07094, KTM07292, KTM07331, KTM07734, KTM07976, KTM07994, KTM08495, KTM08496, KTM10488, KTM13627, KTM13862, KTM16633, KTM16676, KTM16721, KTM17960, KTM17970, KTM18062, KTM19036, KTM19142, KTM19304, KTM20140, KTM20303. HTFA-ASY-0003-W, UDI: 00815381029089, Serial Numbers: KTM00005, KTM00013, KTM00033, KTM00039, KTM00040, KTM00041, KTM00044, KTM00046, KTM00050, KTM00053, KTM00054, KTM00056, KTM00059, KTM00060, KTM00064, KTM00074, KTM00076, KTM00077, KTM00080, KTM00081, KTM00088, KTM00090, KTM00105, KTM00112, KTM00119, KTM00136, KTM00138, KTM00140, KTM00152, KTM00156, KTM00175, KTM00178, KTM00183, KTM00190, KTM00194, KTM00202, KTM00203, KTM00219, KTM00227, KTM00232, KTM00234, KTM00236, KTM00238, KTM00241, KTM00249, KTM00250,KTM00251,KTM00253, KTM00262, KTM00263,KTM00265, KTM00275, KTM00291, KTM00293, KTM00295, KTM00298, KTM00299,KTM00303, KTM00307, KTM00308, KTM00312, KTM00318,KTM00322, KTM00325, KTM00341, KTM00345, KTM00350, KTM00352, KTM00354, KTM00361, KTM00364, KTM00382, KTM00383, KTM00384, KTM00385, KTM00395, KTM00401,KTM00403, KTM00408, KTM00417, KTM00419, KTM00422, KTM00432, KTM00438, KTM00441, KTM00448, KTM00458,KTM00462, KTM00480, KTM00483, KTM00487, KTM00491, KTM00493, KTM00510, KTM00514, KTM00523, KTM00529, KTM00533, KTM00535, KTM00555, KTM00556, KTM00560, KTM00578, KTM00580, KTM00581, KTM00583, KTM00596, KTM00597, KTM00600, KTM00611, KTM00617, KTM00618, KTM00621, KTM00627, KTM00642, KTM00658, KTM00661, KTM00680, KTM00683, KTM00684, KTM00697, KTM00707, KTM00711, KTM00717, KTM00723, KTM00733, KTM00734, KTM00735, KTM00747, KTM00753, KTM00755, KTM00756, KTM00761, KTM00762, KTM00766, KTM00771, KTM00785, KTM00788, KTM00789, KTM00804, KTM00817, KTM00818, KTM00819, KTM00821, KTM00826, KTM00834, KTM00838, KTM00840, KTM00843, KTM00845, KTM00853, KTM00854, KTM00855, KTM00856, KTM00858, KTM00859, KTM00861, KTM00864, KTM00876, KTM00879, KTM00881, KTM00884, KTM00901, KTM00911, KTM00919, KTM00935, KTM00944, KTM00946, KTM00947, KTM00948, KTM00968, KTM00974, KTM00980, KTM00987, KTM00989, KTM00994, KTM00996, KTM00999, KTM009C5, KTM01004, KTM01007, KTM01009, KTM01017, KTM01019, KTM01024, KTM01035, KTM01038, KTM01042, KTM01043, KTM01045, KTM01048, KTM01052, KTM01054,

Risk classification

Class II

Area (FDA)

device

Country

United States