Health product recall

FilmArray Blood Culture Identification (BCID) panel (2020-01-23)

Starting date:
January 23, 2020
Posting date:
February 7, 2020
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-72267

Last updated: 2020-02-07

Affected Products

FilmArray Blood Culture Identification (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 specific Bact/Alert blood culture bottles.

Affected products

FilmArray Blood Culture Identification (BCID) panel

Lot or serial number

All lots.

Model or catalog number

RFIT-ASY-0126
RFIT-ASY-0127

Companies
Manufacturer
BioFire Diagnostics, LLC
515 Colorow Dr
Salt Lake City
84108
Utah
UNITED STATES