BioFire Diagnostics recalls GI Panel kits with false negative results that could lead to incorrect treatment and serious health issues. Affected kits have specific UDI and expiration dates.
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
BioFire Diagnostics is recalling its GI Panel test kits due to reported false negative results. This could lead to incorrect treatments and potentially serious health consequences if the test fails to detect infections.
The GI Panel may produce false negative results, meaning infections could be missed. This might lead to incorrect treatments and potentially serious health events if the test fails to detect infections.
Healthcare providers using the GI Panel test kits are affected. Those who have the specific kit model with UDI (01)00815:381020116 are most at risk.
Check for the UDI code (01)00815381020116 on the kit packaging. The pouch expiration date is May 30, 2020.
Verify the pouch expiration date is May 30, 2020.
Look for the unique device identifier (UDI) (01)00815381020116 on the kit packaging.
Complaints have been received about elevated rates of false negative results with the GI Panel, which could lead to incorrect treatments and serious health events.
Check the UDI code (01)00815381020116 and expiration date (May 30, 2020) on the packaging. If it matches, contact BioFire Diagnostics for guidance.
The recall record does not mention a remedy or fix for the false negative results.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1451-2020 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1451-2020 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.
