ANSM Drug & Device Safety Alert: Recall of Anti-Ig M-PER Reagent

Detected March 25th, 2026

Summary

The French ANSM has announced a recall of a specific lot of the Anti-Ig M-PER reagent used in Hydragel kits by Sebia. This safety action, registered under number R2607839, is intended for medical biology analysis laboratories.

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What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the recall of a specific lot of the Anti-Ig M-PER reagent, manufactured by Sebia, used in their Hydragel 6 CSF MD and Hydragel 6 CSF MS kits. This action, identified by recall number R2607839, is being implemented by the manufacturer and communicated to affected users via direct correspondence.

Medical biology analysis laboratories that have received the affected reagent lot must cease its use and follow the instructions provided by Sebia. While the ANSM is the issuing authority for the alert, direct inquiries and actions should be directed to Sebia. The document includes a link to the manufacturer's letter detailing the recall, dated March 25, 2026, which may contain specific instructions for return or disposal.

What to do next

Cease use of the affected Anti-Ig M-PER reagent lot.
Follow instructions provided by Sebia for recall procedures.
Contact Sebia directly for any questions regarding the recall.

Source document (simplified)

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Rappel n° R2607839 destiné 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 Sebia.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607839. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Sebia (25/03/2026)