medical Class II Updated 2021-03-10

BioFire Diagnostics, LLC recalls Gram-Negative Bacteria And Associated Resistance Markers; F

Recalled Product

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

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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