BioFire recalls Respiratory Panel 2.1 kits that may give false negative results, risking incorrect antibiotic use or delayed treatment for infections.
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 Respiratory Panel 2.1 test kits because they might give false negative results. This could lead to people not getting proper treatment for infections or using antibiotics incorrectly.
The test may produce false negative results when detecting respiratory infections. This could cause healthcare providers to skip treatment, use antibiotics unnecessarily, or delay care for actual infections.
Healthcare providers using the Respiratory Panel 2.1 kits for testing patients. Those at highest risk are clinicians who rely on these tests for infection diagnosis.
Check the kit's lot number on the packaging. The kits were sold with lot numbers 1667923 (expiring June 26, 2024) or 1890223 (expiring July 26, 2024).
Look for lot numbers 1667923 or 1890223 on the packaging.
No, the recall does not require immediate discontinuation. The kits can be used but may give false negatives.
Check the lot number on the packaging. If it matches 1667923 or 1890223, contact BioFire for guidance.
The recall states false negatives might lead to incorrect treatment, but it does not mention serious injury risks.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-0704-2024 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-0704-2024 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.
