Product Wiki · Recalls · Health Canada — Medical Devices

FILMARRAY Blood Culture Identification (BCID) Panel (2019-03-19) — recall 59347

Health Canada — Medical Devices · Canada · 2019-04-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59347
Date of alert
2019-04-29
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: BioFire Diagnostics, LLC has identified an increased risk of false positive Enterobacteriaceae and Escherichia coli results when the BioFire BCID panel is used with bioMérieux bacT/ALERT blood culture bottles. The false positive results are primarily Enterobacteriaceae results with a lower rate of concurrent E. Coli results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/filmarray-blood-culture-identi

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