Health product recall

BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack

Last updated

Summary

Product
BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack
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 catalogue number

BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack

0727226

RFIT-ASY-0147

Issue

BioMérieux has received complaints of false negative results on BIOFIRE BCID2 Panel kit lot 0727226 / pouch lot 3ZQT26 and investigation identified a product issue. This field safety notice is issued due to unintended movement of pouch chemistry in BIOFIRE BCID2 Panel kit lot 0727226, which based on investigation, can lead to an elevated risk of false negative results. All analytes on the panel may be at risk of false negative results. No other BIOFIRE product lots were determined to be impacted.

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
Recall date
Identification number
RA-82873

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