Public recall detail

BIOFIRE® Joint Infection Panel – 30 Pack

2026-08-26

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Health products Health product recall
Quick summary

Quick summary: BIOFIRE® Joint Infection Panel – 30 Pack. Reason: Health product recall. Category: Health products. Date: 2026-08-26.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BIOFIRE® Joint Infection Panel – 30 Pack. Reason: Health product recall. Category: Health products. Date: 2026-08-26.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBiofire Diagnostics, LLC.
ProductBIOFIRE® Joint Infection Panel – 30 Pack
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82530

Affected products

ProductBIOFIRE® Joint Infection Panel – 30 Pack
Lot0806526 (exp. 2027-03-24)
ModelRFIT-ASY-0138
Serial number0806526 (exp. 2027-03-24)
DescriptionBIOFIRE® Joint Infection Panel – 30 Pack
ProductBIOFIRE® Joint Infection Panel – 30 Pack
Lot0677326 (exp. 2027-03-13)
ModelRFIT-ASY-0138
Serial number0677326 (exp. 2027-03-13)
DescriptionBIOFIRE® Joint Infection Panel – 30 Pack
ProductBIOFIRE® Joint Infection Panel – 30 Pack
Lot1289226 (exp. 2027-05-05)
ModelRFIT-ASY-0138
Serial number1289226 (exp. 2027-05-05)
DescriptionBIOFIRE® Joint Infection Panel – 30 Pack

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.

What you should do

  • Contact bioMérieux Canada Inc.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Pathology
CompaniesBiofire Diagnostics, LLC. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Recall date2026-08-18
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82530
Background{}
CompaniesBiofire Diagnostics, LLC. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
AudiencesHealthcare
Source updated2026-08-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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