ANSM Safety Alert: Atellica CH Urine Albumin Reagent

Detected March 26th, 2026

Summary

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Atellica CH Urine Albumin reagent from Siemens Healthcare Diagnostics Inc. The alert, registered under number R2602998, informs medical biology laboratories of a safety action implemented by the manufacturer.

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What changed

The ANSM has issued a safety alert (Information R2602998) concerning the Atellica CH Urine Albumin reagent manufactured by Siemens Healthcare Diagnostics Inc. This alert informs medical biology laboratories that the manufacturer has implemented a safety action. The specific details of this action and the affected parties were communicated directly by Siemens Healthcare Diagnostics Inc. to the relevant users via a letter dated March 26, 2026.

Laboratories using this reagent should review the communication from Siemens Healthcare Diagnostics Inc. for specific instructions and actions required. The ANSM directs any questions regarding this safety action to the manufacturer. The document itself does not specify a compliance deadline or penalties, but implies that adherence to the manufacturer's safety action is expected.

What to do next

Review safety action communication from Siemens Healthcare Diagnostics Inc.
Contact Siemens Healthcare Diagnostics Inc. for any questions regarding the safety action.

Source document (simplified)

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Information n° R2602998 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 Siemens Healthcare Diagnostics Inc.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2602998.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Siemens Healthcare Diagnostics Inc. (26/03/2026)