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