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

Starting date:

March 19, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69614

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

FILMARRAY Blood Culture Identification (BCID) Panel

Reason

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.

Affected products