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FDAFDA · Food and drugs·Recall number Z-1843-2014

FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis. The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blaKPC) to aid in the identification of potentially antimicrobialresistant organisms in positive blood culture samples.

Published July 2, 2014 · Recall initiated: May 27, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
BioFire Diagnostics, Inc.
Distributor
Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.
Lot
426614,424514,424014,421114,419114,419214,417814,416214,416114,411214,411314,411014,410414,410014,408414,406314,404314,402314,403613,700113,698513,695313,692813,689813,689113,686313,685313,677713,668613,665013,667213,667113,663313,663013,665913,657313,659613,651413,647513,644613,632713,424614,424114,419514,419614,418014,416314,416414,412014,412114,411914,409914,406214,404414,700013,698413,695413,692913,689213,685413,668713,665113,667313,662913,657213,663913,660213,651513,647313,622213,
Risk classification
Class II
Area (FDA)
device
Country
United States

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