Health Canada’s 29 October 2026 notice covers specified VITROS Chemistry Products A1c Slides that may produce falsely high HbA1c results. It records a recall date of 22 October. These are laboratory materials, not home glucose meters or continuous glucose monitors.
Which products does the Canadian notice identify?
| Product | VITROS Chemistry Products A1c Slides |
|---|---|
| Company | Ortho-Clinical Diagnostics Inc.; the notice describes the issue confirmed by QuidelOrtho |
| Catalogue number | 684 4520 |
| Canadian recall identifier | RA-82875, Type II |
| Lot or serial numbers | 4200479861 4300467456 4400506596 4300467455 4400506597 4200479860 4300467446 |
Health Canada’s instruction is to contact the manufacturer for further information. People having blood tests will not usually have access to the laboratory’s slide packaging. A laboratory or healthcare service can check whether its materials match the notice.
What does a positively biased result mean?
In this context, positive bias means that the reported A1C may be higher than the value it should have measured. It does not mean the test has detected an infection, and it does not establish that every result produced with the named materials is wrong.
The notice reports 58 complaints received by QuidelOrtho as of 15 October 2026, with no adverse events reported at that point. Those figures are dated: they are not a count of affected patients or proof that no harm could occur. The Canadian notice does not quantify the size of the error in an individual result.
Why A1C accuracy matters
A1C, also written HbA1c, reflects average blood glucose over roughly three months. It is not a reading of glucose at the moment the sample is taken. Clinicians use it alongside other information when diagnosing type 2 diabetes and reviewing diabetes care.
The US National Institute of Diabetes and Digestive and Kidney Diseases explains that A1C and glucose results can sometimes disagree. Differences can have several causes, including conditions affecting red blood cells or haemoglobin, as well as test-related factors. A mismatch is a reason for clinical assessment, not a way to diagnose this recall problem yourself.
Home readings and A1C also describe different time periods. A few current readings cannot automatically prove that an earlier A1C is accurate or inaccurate. Our guide to what HbA1c can and cannot tell you gives more background.
Questions to ask if you are concerned
Start with the clinician who requested the test or the laboratory that processed it. Have the test date and report available. Useful questions include:
- Was my sample tested using the VITROS A1c materials named in this notice?
- Can the laboratory determine whether an affected lot was used?
- Does my result need review in the context of my glucose records and treatment?
- Is any further testing appropriate for my circumstances?
The notice does not require every person who has had an A1C test to arrange a repeat test. That decision belongs with the laboratory and treating clinician. Do not stop insulin, alter medicine doses or abandon your usual monitoring because of a recall headline. A treatment review needs your individual results and clinical circumstances.
What is known outside Canada?
Australia’s Therapeutic Goods Administration records a hospital-level recall of affected VITROS A1c generations, beginning on 21 October 2026. It describes the same concern about results reading too high and instructs customers to stop using and discard the affected materials.
The Australian record uses generation identifiers rather than the Canadian lot list above. Do not assume the identifiers are interchangeable. These records do not, by themselves, establish which laboratories or patients in another country are affected, or the scope of any US action.
Readers outside Canada should use their own regulator’s notice and ask the testing service about the method and materials used. The photograph accompanying this article is a generic laboratory illustration, not a picture of the recalled product.
See our diabetes and patient-safety news for other notices. Keep each product’s instructions separate: an A1C laboratory-material recall is different from a glucose meter, sensor or medicine recall.