Quality & complianceOfficial

Health Canada flags BIOFIRE BCID2 lot over risk of false negative blood culture results

🇨🇦 Health Canada · Wed 28 Oct 2026

A Type II recall covers one kit lot of bioMérieux's BIOFIRE BCID2 Panel after complaints of false negatives, linked to unintended movement of pouch chemistry.

Health Canada has published a Type II recall for one lot of the BIOFIRE Blood Culture Identification 2 (BCID2) 30-pack, made by Biofire Diagnostics, LLC of Salt Lake City, Utah. The notice, reference RA-82873, was posted on 28 October 2026, and the recall date is given as 21 October 2026.

The affected product is kit lot 0727226, catalogue number RFIT-ASY-0147, associated with pouch lot 3ZQT26. BioMérieux received complaints of false negative results on this lot, and its investigation identified a product issue.

According to the notice, the field safety notice was issued because of unintended movement of pouch chemistry in the kit lot. The investigation concluded that this can raise the risk of false negative results. The notice says all analytes on the panel may be affected.

No other BIOFIRE product lots were found to be impacted. The notice lists the issue as a medical device performance problem aimed at healthcare audiences. The only action it gives is to contact the manufacturer for further information.

For context, Health Canada uses Type II for recalls where use of the product may cause temporary or medically reversible health problems, or where the risk of serious harm is considered remote.

What it means for your team

  • Laboratories in Canada should check whether they hold BCID2 kit lot 0727226 (pouch lot 3ZQT26) and contact the manufacturer for instructions.
  • Quality teams may wish to review any results already generated with the affected lot, given that all panel analytes could be at risk of false negatives.
  • Vigilance and regulatory teams should note that the notice names only this lot and states that no other BIOFIRE lots were found to be affected.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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