PharmacovigilanceOfficial

Health Canada lists Type II recall of Vitros A1c slides over positively biased results

🇨🇦 Health Canada · Thu 29 Oct 2026

QuidelOrtho has confirmed that certain generations of Vitros A1c slides may produce positively biased results, with 58 complaints received and no adverse events reported as of 15 October 2026.

Health Canada has published a Type II recall covering Vitros Chemistry Products A1c Slides, made by Ortho-Clinical Diagnostics Inc. The notice, last updated on 29 October 2026, gives a recall date of 22 October 2026 and the identification number RA-82875. It is categorised as a medical device performance issue in haematology.

According to the notice, QuidelOrtho has confirmed that certain generations of the slides may generate positively biased results. As of 15 October 2026, the company had received 58 complaints about the problem. No adverse events have been reported.

Seven lots are listed, all under model or catalogue number 684 4520: 4200479860, 4200479861, 4300467446, 4300467455, 4300467456, 4400506596 and 4400506597. The audience is the healthcare industry, and the only action given is to contact the manufacturer for further information.

For context, a Type II recall in Canada generally applies where use of a product may cause temporary or medically reversible health effects, or where the likelihood of serious harm is remote. The notice does not give a root cause, the number of units affected, or the size of the bias.

What it means for your team

  • Laboratories using Vitros A1c slides should check their inventory against the seven listed lots and model number 684 4520.
  • Quality teams should contact QuidelOrtho for details on the bias, as the notice gives no magnitude, root cause or corrective instructions.
  • Vigilance teams should note that 58 complaints have been recorded but no adverse events, and should keep complaint handling and trending up to date.

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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