Sysmex warns of falsely low results on CN Series coagulation analyzers
A Field Safety Notice published by Dutch inspectorate IGJ says deposits on the Sample Arm B probe of Sysmex CN Series analyzers may produce falsely low measurements.
The Dutch healthcare inspectorate IGJ has published a Field Safety Notice (FSN) from Sysmex Corporation Japan covering its Automated Blood Coagulation Analyzer CN Series. The notice alerts users to a potential risk of falsely low measurement results.
According to the notice, the risk is linked to deposit accumulation on the Sample Arm B probe. The source text does not detail the affected models or serial numbers, the size of the potential error, or the number of devices involved.
The FSN is dated 15 October 2026, and IGJ's listing carries a date of 2 November 2026. The notice is a three-page PDF, available in English. The summary on file indicates that it contains the manufacturer's corrective instructions for laboratories, which users should review, since inaccurate coagulation results could affect clinical decisions.
As general context, manufacturers must monitor their devices after they reach the market and take action when a risk to users emerges. They inform users and the inspectorate of such action through a Field Safety Notice, as IGJ's page also explains.
What it means for your team
- Laboratories operating Sysmex CN Series analyzers should obtain the FSN and check the manufacturer's corrective instructions against their own instruments.
- Quality teams may wish to assess whether any coagulation results produced on affected analyzers need review, in line with local procedures and the manufacturer's guidance.
- Regulatory and vigilance staff should log the FSN, dated 15 October 2026, in their field safety action records and confirm that the affected sites have been informed.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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