Health product recall

Biofire Blood Culture Identification 2 (BCID2) Panel

Last updated

Summary

Product
Biofire Blood Culture Identification 2 (BCID2) Panel
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Biofire Blood Culture Identification 2 (BCID2) Panel

More than 10 numbers, contact manufacturer.

RFIT-ASY-0147

Issue

Biomerieux has observed an increase in customer complaints associated with false positive Serratia marcescens results on the Biofire BCID2 panel when used in conjunction with the following specific lots numbers of culture bottles: 

For BACT/ALERT PF Plus (reference number 410853) Lots: 0004101718 , 0004101790 and 0004101958

For BACT/ALERT FA Plus (reference number 410851) Lots: 0004101930 and 0004102408 

Recall Start Date: June 10, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Biofire Diagnostics, Llc.

515 Colorow Dr., Salt Lake City, Utah, United States, 84108

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75774

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