Changeflow GovPing Healthcare & Life Sciences Murex HBsAg Version 3 Reagent Recall, 847 Units
Urgent Enforcement Amended Final

Murex HBsAg Version 3 Reagent Recall, 847 Units

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Summary

ANSM has been notified of a lot withdrawal conducted by Diasorin affecting 847 units of the Murex HBsAg Version 3 reagent, a diagnostic product used in medical biology laboratories. This safety action is registered under ANSM reference number R2608803. Users have received the Diasorin notification letter directly, and the recalled lot should no longer be used pending further instructions from the issuing firm.

“L'ANSM a été informée de la mise en œuvre d'un retrait de lot effectué par la société Diasorin.”

ANSM , verbatim from source
Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

GovPing monitors ANSM Drug & Device Safety Alerts for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 101 changes logged to date.

What changed

ANSM has recorded a safety action under reference R2608803, confirming that Diasorin has withdrawn a specific lot of its Murex HBsAg Version 3 diagnostic reagent from medical biology laboratories. The withdrawal affects 847 units of the product. Affected laboratories that received the Diasorin notification letter should follow any instructions provided therein and confirm their receipt and disposition of the recalled lot to Diasorin directly. This recall modifies the market status of the identified lot and removes it from diagnostic use pending resolution of the underlying safety concern.

Archived snapshot

Apr 22, 2026

GovPing 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.

Rappel n° R2608803 destiné aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Diasorin.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608803. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Diasorin (22/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 22nd, 2026
Instrument
Enforcement
Branch
Executive
Source language
fr
Legal weight
Binding
Stage
Final
Change scope
Substantive
Docket
R2608803

Who this affects

Applies to
Healthcare providers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Product recall response Market withdrawal Diagnostic reagent distribution
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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