Health product recall

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