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

Recall Z-0296-2019 — 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/

U.S. FDA — Device Enforcement · United States · 2018-09-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0296-2019
Date of alert
2018-09-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BioFire Diagnostics, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00815381020086
Reported risk: Increased risk of false positive results for Proteus when the product is used with a specific 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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