Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1843-2014 · Posted 2014-06-20

Recalling FirmBioFire Diagnostics, Inc.
Recall StatusTerminated
Product CodePAM
Date Initiated2014-05-27
Date Terminated2014-11-07
Product Quantity1084

Reason for Recall

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

Firm Action

BioFire Diagnostics sent an Urgent Recall/Correction letter on May 28, 2014. Customers were instructed If the BCID Panel is used to test BacT/ALERT SN bottles, positive results for Pseudomonas aeruginosa and Enterococcus should be confirmed by another method prior to reporting the test results. Customer with questions were instructed contact customer support at [email protected] or via telephone by dialing 1-800-735-6544 and selecting option 5 for customer support and then option 1 for FilmArray. For questions regarding this recall call 801-736-6354, ext 360.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc. · 2013-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑