medical Class II Updated 2021-03-10

BioFire Diagnostics, LLC recalls BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / U

Recalled Product

BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.

Hazard / Issue

The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
View official government recall

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