BioFire recalls FILMARRAY TORCH MODULE BOX units with specific serial numbers (2022-2024) that may report false positive Salmonella, Giardia, Norovirus, or false negative MRSA results due to calibration issues.
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.
BioFire is recalling certain FILMARRAY TORCH MODULE BOX units made between May 2022 and May 2024 that may report false positive results for Salmonella, Giardia lamblia, Norovirus, or false negative results for MRSA. This could lead to incorrect diagnostic conclusions.
The modules were calibrated with internal equipment that may cause them to report higher melting temperatures. This leads to false positive results for certain pathogens like Salmonella and Giardia lamblia, and false negative results for MRSA.
Users of these diagnostic modules for laboratory testing are affected. The risk is primarily for those using the units for medical testing where false results could impact patient care.
Check if your FILMARRAY TORCH MODULE BOX has the model numbers HTFA-ASY-0003, HTFA-ASY-0003-W, or HTFA-ASY-0003U. Look for the serial numbers listed in the recall notice (e.g., KTM01040, KTM03252, etc.).
Verify if your FILMARRAY TORCH MODULE BOX has the model numbers HTFA-ASY-0003, HTFA-ASY-0003-W, or HTFA-ASY-0003U and the serial numbers listed in the recall notice.
Reach out to BioFire Diagnostics, LLC for assistance with the recall process and to confirm if your unit is affected.
These modules may report false positive results for Salmonella, Giardia lamblia, Norovirus, or false negative results for MRSA, which could lead to incorrect diagnostic conclusions.
Check if your FILMARRAY TORCH MODULE BOX has the model numbers HTFA-ASY-0003, HTFA-ASY-0003-W, or HTFA-ASY-0003U and the serial numbers listed in the recall notice.
No, but you should check if your unit is affected and contact BioFire if needed to ensure accurate testing results.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-3123-2024 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-3123-2024 from BioFire. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
