Health Canada Recalls BIOFIRE Joint Infection Panel Over False Positives

Health Canada has classified a Type II recall for the BIOFIRE® Joint Infection Panel – 30 Pack after the manufacturer, Biofire Diagnostics, LLC., confirmed that certain lots can generate false positive results for KPC, a gene associated with carbapenemase-producing organisms. The recall, identified under Health Canada reference number RA-82530, was dated 2026-08-18 and published on 2026-08-26.

The affected product is a diagnostic test panel used by hospital and laboratory staff to identify pathogens linked to joint infections. Because the panel is a healthcare-facing device rather than a consumer product, the recall notice is directed at laboratories, infectious disease teams and other healthcare audiences that rely on BIOFIRE testing systems rather than at the general public.

What Went Wrong?

According to Health Canada, the company began observing elevated rates of unexpected KPC positives starting April 5, 2026, during reagent final quality control testing. The issue was not limited to the Joint Infection Panel alone — it also turned up during QC testing of the BIOFIRE® FILMARRAY® Pneumonia Panel and the BIOFIRE® FILMARRAY® Pneumonia Panel Plus, suggesting a shared manufacturing or component issue across the product line.

Internal investigation by the manufacturer reproduced the unexpected positive results in failing product, pointing to KPC nucleic acid contamination inside the test pouch itself, at concentrations high enough to trigger false readings. Further testing narrowed the source down further: an isolated component called the outer primer pellet was found to be sufficient on its own to cause the unexpected positive KPC signal. In other words, contamination in a single pellet used during manufacturing could compromise an entire pouch’s result, even in product that had otherwise passed final negativity checks before shipping.

Products Affected by This Recall

The recall covers three specific lots of the BIOFIRE® Joint Infection Panel – 30 Pack, all carrying the model or catalogue number RFIT-ASY-0138:

• Lot 0806526, expiring 2027-03-24
• Lot 0677326, expiring 2027-03-13
• Lot 1289226, expiring 2027-05-05

These lots were distributed by Biofire Diagnostics, LLC., based at 515 Colorow Dr., Salt Lake City, Utah. The company markets its FILMARRAY diagnostic systems, including the Joint Infection Panel, through its parent organization bioMérieux, which handles Canadian distribution through bioMérieux Canada Inc.

Who Should Be Concerned

This recall is relevant to hospital laboratories, clinical microbiology departments and any healthcare facility in Canada that uses the BIOFIRE® Joint Infection Panel to test synovial fluid samples for signs of infection. A false positive KPC result in this context is not a minor lab error — it can influence urgent clinical decisions about antibiotic selection, infection control precautions and patient isolation, particularly where carbapenem-resistant organisms are suspected.

Because the contamination was traced to a manufacturing component rather than to how the test is stored or handled at the point of care, facilities using any of the listed lots may be affected regardless of when or how the product was used, provided it falls within the recalled batches.

Steps Healthcare Facilities Should Take

Health Canada’s summary directs affected users to contact bioMérieux Canada Inc. directly for guidance on the recalled lots. Facilities should check their inventory against the three lot numbers listed above and set aside any matching stock rather than continuing routine use, pending instructions from the manufacturer.

Laboratories that have already reported a KPC positive result using one of the affected lots may want to flag those results for clinical review, given the documented risk of contamination-driven false positives. Any adverse events or product performance concerns tied to this issue can also be reported to Health Canada through its national reporting channel for health or safety concerns.

From the Agency

Health Canada’s notice describes the issue plainly as a ‘Medical devices – Performance’ concern, placing it in the Pathology category of its health product recall system. The recall is formally logged as a Type II class action, a designation Health Canada uses for situations where a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

The agency’s listing does not specify a total unit count for the affected lots, but it confirms the recall status as active as of its last update on 2026-08-26 and continues to direct healthcare users toward the manufacturer for lot-specific follow-up.