FDA Device recall Z-3123-2024
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U by Biofire Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3123-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-07 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
Product
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Reason
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.
Identifiers
| code_info | HTFA-ASY-0003, UDI: 00815381020277, Serial Numbers: KTM01040, KTM03252, KTM05330, KTM05411, KTM05602, KTM05734, KTM0580…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Biofire Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3123-2024%22
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