Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1133-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-03-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1133-2019
Date of alert
2019-03-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BioFire Diagnostics, LLC
Product category
device
Product type
Devices
Reported risk: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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