Biofire Blood Culture Identification 2 (BCID2) Panel
Brand(s)
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 specific lots numbers of BACT/ALERT PF Plus and BACT/ALERT FA Plus culture bottles.
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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