Recall MonitorHealth Products
BIOFIRE® Joint Infection Panel – 30 Pack
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Pathology
Product: BIOFIRE® Joint Infection Panel – 30 Pack
Issue: Medical devices - Performance
What to do: Contact bioMérieux Canada Inc.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| BIOFIRE® Joint Infection Panel – 30 Pack | 0806526 (exp. 2027-03-24) | RFIT-ASY-0138 |
| BIOFIRE® Joint Infection Panel – 30 Pack | 0677326 (exp. 2027-03-13) | RFIT-ASY-0138 |
| BIOFIRE® Joint Infection Panel – 30 Pack | 1289226 (exp. 2027-05-05) | RFIT-ASY-0138 |
Issue
Beginning April 5, 2026, elevated rates of KPC unexpected positives were observed in reagent final QC testing of the BIOFIRE® FILMARRAY® Pneumonia Panel, BIOFIRE® FILMARRAY® Pneumonia Panel Plus, and BIOFIRE® Joint Infection Panel, including in passing product that met final QC negativity requirements. Internal testing of failing product has reproduced KPC unexpected positive results, suggesting KPC nucleic acid (organism or synthetic) contamination in the pouch at levels that can lead to false positive results. Additional testing has confirmed that an isolated component, the outer primer pellet, is sufficient for producing unexpected positive KPC results.