BioFire Diagnostics recalls Respiratory Panel 2.1 kits due to false negative results and control failures from pouch chemistry movement. Affected kits have specific UDI and lot numbers.
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
BioFire Diagnostics is recalling its Respiratory Panel 2.1 test kits because pouch chemistry can move unintentionally, leading to false negative results and control failures. This could mean tests don't detect infections properly, potentially missing illnesses.
The pouch chemistry in the test kit can move unintentionally during use, causing the test to show false negative results (meaning infections are missed) and control failures (tests not working as expected).
Healthcare providers using the BioFire Respiratory Panel 2.1 test kits with UDI 00815381020529 or lot #2649724 are affected. Lab staff and clinics using these kits are most at risk.
Check for the UDI code 00815381020529 or lot number 2649724 on the kit's label. The product is a 30-test kit sold under the BioFire Respiratory Panel 2.1 brand.
Look for the UDI code 00815381020529 or lot number 2649724 on the test kit's label.
The pouch chemistry in the BioFire Respiratory Panel 2.1 test kits can move unintentionally, leading to false negative results and control failures.
If you have the affected kit, tests might miss infections, so it's important to check the label for the UDI code or lot number.
Check the kit's label for UDI 00815381020529 or lot number 2649724. The product is a 30-test kit sold under the BioFire Respiratory Panel 2.1 brand.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-0602-2026 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-0602-2026 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.
