FDAFDA · Alimentos y medicamentos·N.º oficial Z-3123-2024
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Publicado el 18 de septiembre de 2024 · Inicio del retiro: 7 de agosto de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BioFire Diagnostics, LLC
- Distribuidor
- 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.
- Lote
- 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,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.