Anti-Lea Reagent Safety Alert - Diagast Immuno-Hematology
Summary
ANSM issued safety alert R2610123 regarding a security action taken by Diagast for its Anti-Lea Reagent (LE1) used in immuno-hematology testing. Medical biology laboratories using this diagnostic reagent must review the manufacturer's safety communication and take appropriate action. ANSM reference number R2610123.
What changed
ANSM issued safety alert R2610123 notifying medical biology laboratories of a security action performed by Diagast for its Anti-Lea Reagent (LE1) used in immuno-hematology testing. The alert references a manufacturer communication dated 10/04/2026 that users have received directly.
Medical laboratories using Diagast immuno-hematology reagents must review the manufacturer's safety communication, verify whether they hold affected products, and implement any required corrective actions. This alert represents a substantive safety action affecting diagnostic testing procedures in clinical laboratory settings.
What to do next
- Review the Diagast manufacturer communication for Anti-Lea Reagent safety action
- Identify and quarantine any affected Diagast Anti-Lea Reagent products in your laboratory
- Report any adverse incidents related to the reagent to ANSM
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Information n° R2610123 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 Diagast.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2610123. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Diagast (10/04/2026)
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