Biofire Blood Culture Identification 2 (BCID2) Panel
Brand(s)
Last updated
Summary
Product
Biofire Blood Culture Identification 2 (BCID2) Panel
Issue
Medical devices - Performance issue
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 of BACT/ALERT PF Plus (reference number 410853) culture bottles: lots 0004101718 , 0004101790 and 0004101958.
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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