BioFire? FilmArray? Blood Culture Identification (BCID) Panel (2021-01-27)
- Starting date:
- January 27, 2021
- Posting date:
- February 12, 2021
- 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-74989
Last updated:
2021-02-12
Affected Products
BioFire? FilmArray? Blood Culture Identification (BCID) Panel
Reason
An increased amount of customer complaints were received by BioFire Diagnostics regarding false positive Pseudomonas aeruginosa results when using BioFire? Filmarray? Blood Culture Identification (BCID) Panel (part no.: RFIT-ASY-0126 and RFIT-ASY-0127) with BD BACTEC blood culture vials.
Affected products
BioFire? 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