Health Canada Flags Vitros A1c Slides Recall Over Biased Test Results 2026

Health Canada has classified a recall of Vitros Chemistry Products A1c Slides as Type II after the manufacturer confirmed that certain generations of the slides may produce positively biased results. The recall was dated 2026-10-22 and published by the department on 2026-10-29 under identification number RA-82875.

The slides are made by Ortho-Clinical Diagnostics Inc., a company that operates as QuidelOrtho. The notice is aimed at healthcare professionals and industry, since the slides are laboratory products and not items sold to the general public.

Quick Facts

• Product: Vitros Chemistry Products A1c Slides
• Model or catalogue number: 684 4520
• Recall class: Type II
• Recall number: RA-82875
• Recall date: 2026-10-22
• Complaints received: 58 as of 15-Oct-2026
• Adverse events reported: None

Products Affected by This Recall

The recall covers seven lots of Vitros Chemistry Products A1c Slides, all under model or catalogue number 684 4520. Health Canada lists the following lot or serial numbers:

• 4200479860
• 4200479861
• 4300467446
• 4300467455
• 4300467456
• 4400506596
• 4400506597

The product is classed under health products, medical devices and haematology. The issue is categorized as a medical device performance problem.

What Triggered the Recall

QuidelOrtho confirmed an issue involving the A1c slides. Certain generations of the slides may generate positively biased results. In practical terms, that means a result can come back higher than it should.

As of 15-Oct-2026, the company had received 58 complaints relating to the issue. The notice states that no adverse events have been reported. The source does not give the number of units affected, and it does not describe the cause of the bias.

Who Should Be Concerned

The audience listed for this notice is healthcare and industry. Laboratories and healthcare facilities that use Vitros A1c slides should check their inventory against the lot numbers above. Anyone who relies on A1c results from these systems may also want to know the issue exists, although the notice does not tell patients to take any specific action.

The manufacturer’s address is listed as 100 Indigo Creek Drive, Rochester, New York, United States, 14626. Health Canada published the notice because the affected products are relevant to the Canadian market.

How to Respond to This Recall

The instruction in the Health Canada notice is short: contact the manufacturer if you require additional information. No refund process, replacement program or return steps are described in the source.

• Check your slide inventory against the seven lot numbers and model number 684 4520.
• Contact QuidelOrtho or Ortho-Clinical Diagnostics Inc. for further information about the affected lots.
• Ask the manufacturer for guidance on any results already generated with the affected generations of slides.
• Patients with questions about an A1c result should speak with their healthcare provider or the laboratory that ran the test.

Regulatory Response

Health Canada published the alert as a health product recall for medical devices. A Type II classification is used when a product may cause temporary or medically reversible effects, or when the risk of serious harm is considered remote. The notice itself does not spell out that definition, so readers should treat it as general context and not as a statement from this specific alert.

The department’s notice says QuidelOrtho has confirmed the issue and that no adverse events have been reported to date. Health Canada also invites readers to subscribe to recall email notifications and to report any health or safety concern through its official channels.

Because the notice was only recently issued, further updates may follow. Laboratories using these slides should watch for communication from the manufacturer and check the Health Canada recalls page for changes to the notice.