BioFire Diagnostics recalls GI Panel due to potential false negatives causing inappropriate antibiotic use or delayed treatment. Affected kits have specific lot numbers and expiration dates.
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
BioFire Diagnostics recalls its GI Panel diagnostic test because it may produce false negative results. This could lead to incorrect antibiotic use, no treatment, or delayed treatment for infections. The recall affects kits with specific lot numbers and expiration dates.
The test may give false negative results, meaning infections could be missed. This might lead to incorrect antibiotic treatment, no treatment at all, or delayed treatment for infections. It could also cause false reassurance about an infection and delay outbreak identification.
Healthcare providers using the GI Panel for diagnostic testing. Those at highest risk are clinicians who rely on the test for infection detection.
Check the kit lot/pouch lot numbers on the packaging: 1749723/2XKB23 or 1746223/2XJA23. The expiration date is July 6, 2024.
Look for lot numbers 1749723/2XKB23 or 1746223/2XJA23 on the packaging.
BioFire Diagnostics recalls its GI Panel diagnostic test due to potential false negative results that could lead to incorrect antibiotic use or delayed treatment.
Check the kit lot/pouch lot numbers: 1749723/2XKB23 or 1746223/2XJA23. The expiration date is July 6, 2024.
The official recall notice does not specify a remedy or action for affected products.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0703-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-0703-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
