FDAJanuary 26, 2021device
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
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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