FilmArray Blood Culture Identification Panel (BCID) Panel (2018-09-06)

Starting date:

September 6, 2018

Posting date:

October 5, 2018

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-67878

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  Reason
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  Affected products

Affected products

FilmArray Blood Culture Identification Panel (BCID) Panel

Reason

BioFire Diagnostics, LLC has identified an increased risk of false positive proteus results when the Filmarray Blood Culture Identification (BCID) panel is used with BacT/ALERT Culture media with expiration dates of 2019-05-02 and beyond. The intended function of BacT/ALERT Blood culture bottles (culturing viable microorganisms) is not compromised by this anomaly. It is unknown if subsequent lots of media will also be subject to this risk.

Affected products