Nova Biomedical pulls two ketone strip lots in Canada after control-check problems
Health Canada has listed a Type II recall of model 66841 strips; it says whole-blood patient results are unaffected, and no financial impact has been disclosed.
Nova Biomedical, the Waltham, Massachusetts-based diagnostics maker, is recalling two production lots of its StatStrip Ketone Test Strips in Canada. Health Canada's notice does not say what the action will cost the company or how many strips are involved.
The lots are 2224295249 and 2226117249, both sold under model number 66841. According to the regulator, the strips produced control-solution test failures more often than expected when used. The stated aim of the recall is to avoid delays in producing ketone results. Health Canada says testing of patients' whole blood is not affected.
The notice carries identification number RA-82918, gives a recall date of 23 October 2026 and was published on 5 November. It is addressed to healthcare audiences. It does not lay out its own steps: users are told to check whether they hold the affected strips, stop using them, and follow the manufacturer's recall notification, with the manufacturer as the point of contact for further information.
By way of context, Health Canada's Type II category generally covers products that may cause temporary or medically reversible health effects, or where serious harm is considered unlikely. The notice gives no sign of a wider product withdrawal, a replacement timetable or any supply disruption, and it is silent on sales exposure, so the commercial consequences cannot be judged from the public record.
Why it matters
- The recall is limited to two lots of one catalogue number, and the notice discloses no volumes, costs or supply-gap details.
- The stated problem is the failure of in-use control checks, not a reported effect on patient whole-blood results, which Health Canada says is unaffected.
- Hospital and point-of-care laboratories that stock the strips face a stock check and quarantine exercise, and the main reference points are RA-82918 and the manufacturer's own notification.
- Nothing in the notice allows any conclusion about Nova Biomedical's wider financial performance or market position.
Official record: Health Canada ↗
Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.