ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5

ANSM Drug & Device Safety Alerts

Published March 17th, 2026

Detected March 17th, 2026

Summary

The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.

View original document View source feed page

What changed

The French National Agency for Food and Drug Safety (ANSM) has issued a safety information notice (R2607353) concerning the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. This notice indicates a safety action implemented by the manufacturer, with affected users having received direct communication. The ANSM is registering this action, and further details are available in the company's letter dated March 17, 2026.

Medical laboratories using this reagent should review the safety action communicated by Diagnostica Stago. While the ANSM notice directs inquiries to the manufacturer, laboratories must ensure they have received and understood the company's safety letter. Compliance with any recommended actions from Diagnostica Stago is crucial to maintain patient safety and regulatory adherence.

What to do next

Review the safety action letter from Diagnostica Stago dated 2026-03-17.
Ensure all relevant personnel are aware of the safety information and any required procedures.

Source document (simplified)

A+ A-

Information n° R2607353 destinée aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Diagnostica Stago.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607353.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Diagnostica Stago (17/03/2026)