BIOFIRE Blood Culture Identification 2 (BCID2), 30-Pack
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
| Biofire Diagnostics, Llc. |
| 515 Colorow Dr., Salt Lake City, Utah, United States, 84108 |
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