BioFire Diagnostics recalls GI test kits that may give false positive Vibrio results when used with Remel Cary Blair transport medium. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
BioFire Diagnostics is recalling two gastrointestinal test kits that may produce false positive results for Vibrio/Vibrio Cholerae when used with Remel Cary Blair transport medium. This could lead to incorrect diagnoses of serious infections if the test is used without proper handling.
The test may show false positive results for Vibrio or Vibrio Cholerae when the Cary Blair transport medium is used. This could lead to unnecessary treatment or missed infections if the test is not properly handled.
Individuals using the BioFire GI Panel test kits with Remel Cary Blair transport medium for stool samples. Those testing for gastrointestinal infections are most at risk of incorrect results.
Check for product part numbers RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit). The kits are affected if used with Remel Cary Blair transport medium lot numbers 743930, 769240, 712258, 782425, 732357, or 742049.
Identify if your BioFire GI Panel kit has part numbers RFIT-ASY-0116 (30 tests) or RFIT-ASY-0104 (6 tests).
Confirm if you used Remel Cary Blair transport medium with the kit, as this may cause false positive results.
No, the recall does not require stopping use. The kits may still be used with other transport media to avoid false positives.
The recall specifically mentions Remel Cary Blair transport medium lot numbers 743930, 769240, 712258, 782425, 732357, and 742049.
Yes, if you use a different transport medium, the test should work correctly without false positives.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2514-2024 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2514-2024 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.
