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OFFICIAL-SOURCE RECALL · CANADA
BIOFIRE® Joint Infection Panel – 30 Pack Recall: Beginning April 5, 2026, elevated rates of KPC
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryCanadaPublishedAugust 26, 2026Last updatedAugust 26, 2026Official source last checkedAugust 26, 2026 at 6:15 PM UTC
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- BIOFIRE® Joint Infection Panel – 30 Pack
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Why this product was recalled
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.
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.
Official recall notice
BIOFIRE® Joint Infection Panel – 30 Pack
Agency: Health Canada
Official publication date: August 26, 2026
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