BioFire FILMARRAY TORCH Module Recall Due to Calibration Errors
BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves high-risk pathogens (Salmonella, MRSA) and the potential for false negative results, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling 3,439 units of FILMARRAY TORCH Module Boxes (HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U). The affected modules were manufactured or serviced between May 2022 and May 2024. These products were distributed nationwide in the US and internationally to countries including Canada, China, Korea, and Australia.
The recall is due to a calibration issue with internal equipment that may cause the modules and instruments to report higher melting temperatures. This defect can lead to erroneous diagnostic results, including false positive Salmonella and Giardia lamblia, false positive or negative Norovirus, and false negative MRSA.
Healthcare facilities and laboratories should check their inventory for the specific serial numbers listed in the recall notice. Users should stop using the affected modules and contact BioFire Diagnostics for instructions on replacement or return.
The recalled product
- Product
- FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 3,439
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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