FDAMarch 7, 2019device
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
What to do
FDA enforcement status: Terminated
Brands named
biofire diagnosticsbiofire
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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