medical Class II Updated 2018-11-07

BioFire Diagnostics, LLC recalls FilmArray Blood Culture Identification (BCID), IVD, Rx Only

Recalled Product

FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, 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,

Hazard / Issue

Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots.
View official government recall

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