Quality & complianceOfficial

Sysmex CN-Series Coagulation Analyzers Recalled in Canada Over Probe Deposits and Falsely Low Results

🇨🇦 Health Canada · Fri 06 Nov 2026

Health Canada has published a Type II recall of Sysmex CN-3000 and CN-6000 analyzers after deposits on the sample arm B probe were found to risk reduced sample volumes.

Health Canada has published a recall of Sysmex CN-series automated blood coagulation analyzers, listed under identification number RA-82927. The recall date is 29 October 2026 and the notice was posted on 6 November 2026. The regulator classes it as Type II and the stated issue is medical device performance.

According to the notice, the legal manufacturer Sysmex informed Siemens Healthineers in October 2026 of an urgent field safety notice for the CN-series systems. Sysmex found that deposits may build up on the sample arm B probe. These deposits can interfere with sample dispensing, so less sample than intended may reach the reaction cuvette. The result may be falsely decreased test values.

The manufacturer's investigation attributed the build-up to insufficient washing of the sample arm B probe. Health Canada states that this occurred independently of the assays used, so the issue is not tied to a particular test.

The affected products are the CN-3000 and CN-6000 models. For the CN-3000, the listing says that more than 10 numbers are affected and directs users to the manufacturer for the full range. The CN-6000 entries carry catalogue numbers Q1078 and Q1079, with serial numbers AX801645 and CV339763 shown in the notice. The listing is not entirely clear on how model, catalogue and serial identifiers line up, so users should check against the manufacturer's own documentation.

Health Canada's advice is limited to contacting the manufacturer for further information. The notice gives no corrective actions, such as cleaning procedures or software changes. As general context, a Type II recall in Canada covers products that may cause temporary or medically reversible health effects, or where serious harm is unlikely.

What it means for your team

  • Laboratories in Canada running CN-3000 or CN-6000 analyzers should check their serial and catalogue numbers against the notice and contact the manufacturer, as the CN-3000 list is incomplete in the public text.
  • Quality and laboratory teams may wish to assess whether the risk of falsely decreased coagulation results requires a review of past results. The notice itself gives no guidance on this.
  • Regulatory teams should note that the field safety notice reached Health Canada via Siemens Healthineers and that the public notice contains no corrective-action details, so the manufacturer's notice should be obtained directly.

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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