FDAMay 10, 2021device
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
biofire diagnosticsbiofire
UPCs
00815381020338
Recall history
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