BioFire Diagnostics recalls FILMARRAY 2.0 instruments from May 2022-May 2024 that may report false positive Salmonella, Giardia, and Norovirus 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 Diagnostics is recalling FILMARRAY 2.0 instruments produced between May 2022 and May 2024 that may report false positive results for Salmonella, Giardia, and Norovirus. This could lead to incorrect health decisions if used for diagnostic testing.
The instruments were calibrated with internal equipment that may cause them to report higher melting temperatures. This leads to false positive results for Salmonella, Giardia lamblia, Norovirus, and false negative results for MRSA. The false results could lead to incorrect health decisions if used for diagnostic testing.
Laboratory users who purchased FILMARRAY 2.0 instruments with serial numbers listed in the recall notice between May 2022 and May 2024. The risk is primarily for those using the instruments for diagnostic testing where false results could impact health decisions.
Check if your FILMARRAY 2.0 instrument has a serial number listed in the provided list (2FA00610, 2FA00951, and other serial numbers) or was manufactured between May 2022 and May 2024.
Verify your FILMARRAY 2.0 instrument's serial number against the list of affected units provided in the recall notice.
BioFire Diagnostics recalls FILMARRAY 2.0 instruments manufactured between May 2022 and May 2024 that may report false positive results for Salmonella, Giardia lamblia, and Norovirus due to calibration issues.
Check your instrument's serial number against the list provided in the recall notice. If it matches, contact BioFire Diagnostics for further instructions.
The recall addresses potential false results that could lead to incorrect health decisions, but there is no indication of direct harm to users from the instrument itself.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-3122-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-3122-2024 from BioFire Diagnostics. 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.
