medical Class II Updated 2018-05-02

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

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.
View official government recall

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