FDAJune 19, 2024device

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853

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

The hazard

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

What to do

FDA enforcement status: Ongoing

Brands named

biofire diagnosticsbiofire

UPCs

008153810203380357302659605703573026596095

Recall history

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

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