BioFire Diagnostics recalls GI panels with potential for false positive Norovirus results. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
BioFire Diagnostics is recalling two gastrointestinal test kits because they may produce false positive results for Norovirus. This could lead to incorrect diagnoses and unnecessary treatments if used without proper verification.
The GI panels may generate false positive Norovirus results, which could lead to incorrect patient diagnoses. This might cause unnecessary treatments or delays in proper care if not addressed.
Laboratories and healthcare facilities using the recalled GI panels for testing. Those most at risk are labs that rely on these kits for patient diagnostics.
Check for part numbers RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit) on the product packaging. The recall covers kits sold by BioFire Diagnostics.
Verify the part number on the packaging to confirm if it matches RFIT-ASY-0116 (30 test kit) or RFIT-ASY-0104 (6 test kit).
The recall is due to potential signals of increased false positive Norovirus results when using the gastrointestinal panel.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates a risk of false positive results, but no immediate safety hazards like injury or death are mentioned.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1140-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1140-2024 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.
