Quality & complianceOfficial

Health Canada flags recall of two Nova StatStrip ketone test strip lots over QC failures

🇨🇦 Health Canada · Thu 05 Nov 2026

Nova Biomedical's StatStrip Ketone Test Strips, model 66841, are being recalled in Canada after affected lots showed more quality control failures during use, though patient blood results are unaffected.

Health Canada has published a Type II recall covering two lots of Nova StatStrip Ketone Test Strips made by Nova Biomedical Corporation. The affected lots are 2224295249 and 2226117249, both under model or catalogue number 66841.

According to the notice, the lots showed an increased rate of quality control (QC) test failures in use. The recall is being carried out to prevent delays in obtaining ketone test results. Health Canada states that patient whole-blood testing performance is not affected.

Users are told to identify the affected strips and stop using them immediately, then follow the instructions in the recall notification. Those needing more information should contact the manufacturer. The notice is aimed at healthcare audiences.

The recall date is listed as 23 October 2026, and the notice was published on 5 November 2026 under identification number RA-82918. The manufacturer is based in Waltham, Massachusetts. For context, a Type II recall in Health Canada's system generally concerns products that may cause temporary or medically reversible health effects, or where serious harm is considered unlikely.

What it means for your team

  • Laboratory and point-of-care teams in Canada should check stock and in-use inventory for lots 2224295249 and 2226117249 of model 66841 and quarantine any found.
  • Quality teams should follow the manufacturer's recall notification for the required actions, as the Health Canada page directs users there rather than setting out its own steps.
  • Repeated QC failures are the stated trigger, so sites may wish to review their own QC records for the affected lots, with the caveat that Health Canada reports no effect on patient whole-blood performance.
  • Regulatory teams with devices distributed in Canada should note the Type II classification and reference RA-82918 for tracking.

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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