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FDAApril 30, 2025device

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

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

The hazard

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

What to do

FDA enforcement status: Ongoing

Brands named

biofire diagnosticsbiofire

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 plus Kit, REF: 423740, For Filmarray systems — Recall Details · AllClear