BioFire Diagnostics recalls FilmArray GI Panel kits with possible false negative results due to manufacturing issues. Affected kits include specific lot numbers and model.
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
BioFire Diagnostics is recalling its FilmArray Gastrointestinal (GI) Panel kits because a manufacturing issue could cause false negative results. This means the test might incorrectly show no infection when one is present, potentially leading to missed diagnoses.
The manufacturing issue causes the GI Panel to sometimes give false negative results, meaning infections could be missed. This happens because the test might not detect the presence of certain pathogens when they are actually there.
Healthcare providers using the FilmArray GI Panel kits for testing are likely affected. Those who have the specific lot numbers (Pouch Lot# 2N3R22 / Kit Lot# 2160422) are most at risk.
Check the pouch lot number (2N3R22) and kit lot number (2160422) on the packaging. The product is sold under the FilmArray Systems brand with the reference number RFIT-ASY-0116.
Look for pouch lot number 2N3R22 and kit lot number 2160422 on the packaging.
Due to a manufacturing issue, the FilmArray GI Panel may result in false negative results.
The recall does not specify a remedy, so check the lot numbers and contact BioFire Diagnostics for further instructions.
No, the hazard is limited to potential false negative results, which do not cause physical harm.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1392-2023 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1392-2023 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.
