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