CanadaWhat's being recalled
Companies: Biofire Diagnostics, Llc., 515 Colorow Dr., Salt Lake City, Utah, United States, 84108.
How to identify it
Affected products: BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack; Lot or serial number: 0727226; Model or catalogue number: RFIT-ASY-0147
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)