Sysmex coagulation analyser recall in Canada flagged through Siemens Healthineers

Health Canada has added a recall of Sysmex CN-3000 and CN-6000 coagulation analysers to its database, under reference RA-82927. The action is dated 29 October 2026 and was posted on 6 November. The notice does not give the number of instruments affected, any cost to the companies or any effect on sales, so the commercial impact cannot be assessed from the public record.

The notice names Sysmex as the legal manufacturer. It says Sysmex told Siemens Healthineers in October of a customer safety notice covering the CN-series systems, and the matter reached the Canadian regulator through that route. Sysmex found that residue can build up on one of the analyser's sample-dispensing probes, known as sample arm B. That can leave the reaction vessel with less sample than intended and produce results that read too low. The manufacturer traced the build-up to inadequate washing of the probe. Health Canada says the problem occurs whatever assay is being run, so it is not confined to one test.

Health Canada classes the recall as Type II. As general context, in Canada that category covers products that may cause temporary or medically reversible health effects, or where serious harm is unlikely. The regulator's only instruction is that users contact the manufacturer. The notice describes no corrective steps, such as a cleaning routine or a software change, and no timetable for a fix.

Identification of affected units is also unclear. For the CN-3000, the listing says more than 10 numbers are affected and refers readers to the manufacturer for the full range. The CN-6000 entries show catalogue numbers Q1078 and Q1079 and serial numbers AX801645 and CV339763. The way the model, catalogue and serial identifiers line up in the listing is not clear, so the manufacturer's own documentation is the reliable reference.