Changeflow GovPing Pharma & Drug Safety Recall Mycology Yeastone Broth 11ML Remel - R26...
Urgent Enforcement Amended Final

Recall Mycology Yeastone Broth 11ML Remel - R2609813

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Summary

ANSM registered safety action R2609813 for Mycology Yeastone Broth 11ML Remel following a lot withdrawal initiated by Thermo Fisher. Medical biology laboratories that received the affected product have been notified directly by Thermo Fisher. This recall addresses a safety concern with specific lots of the reagent used in mycological testing.

What changed

ANSM registered safety action R2609813 confirming a lot withdrawal of Mycology Yeastone Broth 11ML Remel conducted by Thermo Fisher. Affected users have received direct notification from Thermo Fisher with specific instructions. The recall is classified as a safety action, indicating potential risk associated with the identified lots.\n\nMedical biology laboratories using this mycological reagent must immediately identify any remaining inventory of the affected lots, cease use, and follow the return/disposal instructions provided in the Thermo Fisher correspondence. Laboratories should also review their quality management documentation to ensure affected results are not compromised and consider any patient notification if test results may have been impacted.

What to do next

  1. Check laboratory inventory for Mycology Yeastone Broth 11ML Remel lot R2609813
  2. Quarantine and stop using any affected lots immediately
  3. Follow Thermo Fisher's instructions in the notification letter for lot return or disposal

Archived snapshot

Apr 9, 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.

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Rappel n° R2609813 destiné aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’un retrait de lots effectué par la société Thermo Fisher.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609813. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Thermo Fisher (09/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 9th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2609813

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Laboratory reagent recall Medical device safety action Lot withdrawal
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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