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FDAJanuary 26, 2024device

BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identifica...

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

The hazard

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

What to do

FDA enforcement status: Ongoing

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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