Official recall record

Automated Blood Coagulation Analyzers

What the authority reported

In October 2026, the legal manufacturer Sysmex notified Siemens Healthineers of an urgent field safety notice for the analyzer CN series systems. Sysmex identified that deposits may accumulate on the sample arm B probe of the CN-series analyzers. The deposits may affect sample dispensing, potentially resulting in the delivery of a lower sample volume to the reaction cuvette than defined, which and may cause falsely decreased results. Based on the manufacturer's investigation, the accumulation of deposits occurred due to insufficient washing of the sample arm B probe independent from the assays used.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: Health Canada — Medical Devices · Canada · all filters