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FDAOctober 11, 2021device

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vial...

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

The hazard

Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.

What to do

FDA enforcement status: Terminated

Brands named

biofire diagnosticsbiofire

UPCs

00815381020338

Recall history

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

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BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vial... — Recall Details · AllClear