BioFire Diagnostics, LLC recalls FilmArray BCID Panel (Blood Culture Identification Panel), C
Recalled Product
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Hazard / Issue
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Issued by
FDA
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