ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent

ANSM Drug & Device Safety Alerts

Published March 17th, 2026

Detected March 17th, 2026

Summary

The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has announced a safety recall, registered under number R2532493, concerning a specific lot of the Autoimmunity IDS SS-A/Ro reagent from Immunodiagnostic Systems (IDS). This action is a product recall, indicating a potential safety issue or defect with the reagent.

Laboratories that have received the affected reagent lot must take immediate action as directed by Immunodiagnostic Systems (IDS). While the ANSM directs inquiries to the manufacturer, affected entities should consult the provided letter from IDS dated March 17, 2026, for specific instructions on handling the recalled product, which may include returning or discarding the reagent. Failure to comply with recall procedures could have implications for patient safety and laboratory accreditation.

What to do next

Review correspondence from Immunodiagnostic Systems (IDS) regarding recall R2532493.
Implement necessary actions for the affected lot of Autoimmunity IDS SS-A/Ro reagent as instructed by IDS.
Contact Immunodiagnostic Systems (IDS) directly for any questions or clarification.

Source document (simplified)

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Information de rappel n° R2532493 destinée aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre du retrait d’un lot effectué par la société Immunodiagnostic Systems (IDS).
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2532493.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Immunodiagnostic Systems (IDS) (17/03/2026)