BioFire recalls respiratory/sore throat test panels with risk of false negatives and control failures. Affected units include REF: 42348: 2215125 lot numbers.
Respiratory/sore throat panel test may result in false negative results and control failures.
BioFire Diagnostics recalls its Spotfire Respiratory/Sore Throat Panel (REF: 423485) because it may give false negative results and control failures. This could lead to incorrect health assessments if used for testing.
The panel may produce false negative results, meaning it could miss infections. Control failures might prevent the test from working properly, leading to incorrect health conclusions.
People who purchased or use the BioFire Spotfire Respiratory/Sore Throat Panel REF: 423485. Those testing for respiratory or sore throat symptoms are most at risk of inaccurate results.
Check for the product code REF: 423485 and lot number 2215125 on the panel. The unique identifier (UDI) starts with 00815381020390.
Look for the product code REF: 423485 and lot number 2215125 on the panel.
The product code is REF: 423485.
Lot number 2215125 is affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2081-2026 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2081-2026 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.
