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FDAOctober 22, 2025device

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

What to do

FDA enforcement status: Ongoing

Brands named

biofire diagnosticsbiofire

UPCs

00815381020529

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — Recall Details · AllClear