CanadaThe BIOFIRE Joint Infection Panel – 30 Pack (model RFIT-ASY-0138) with lot numbers 0806526 (exp. 2027-03-24), 0677326 (exp. 2027-03-13) and 1289226 (exp. 2027-05-05) is affected. Internal testing reproduced unexpected positive KPC results caused by KPC nucleic acid (organism or synthetic) contamination in the pouch, and the outer primer pellet was sufficient to produce false positive KPC results. Contact bioMérieux Canada Inc.
What's being recalled
Companies: Biofire Diagnostics, LLC., 515 Colorow Dr., Salt Lake City, Utah, United States, 84108.
How to identify it
Affected products: BIOFIRE® Joint Infection Panel – 30 Pack; Lot or serial number: 0806526 (exp. 2027-03-24); Model or catalogue number: RFIT-ASY-0138
Affected products: BIOFIRE® Joint Infection Panel – 30 Pack; Lot or serial number: 0677326 (exp. 2027-03-13); Model or catalogue number: RFIT-ASY-0138
Affected products: BIOFIRE® Joint Infection Panel – 30 Pack; Lot or serial number: 1289226 (exp. 2027-05-05); Model or catalogue number: RFIT-ASY-0138
The hazard
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.
What to do
Contact bioMérieux Canada Inc.
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)