medical Class II Updated 2021-06-30

BioFire Diagnostics, LLC recalls BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray System

Recalled Product

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338


Hazard / Issue

Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
View official government recall

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