PV Bulletin

ANSM (France) - Safety information feed: Mycologie – Réactif Yeastone Broth, 11ML – Thermo Fisher Scientific sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sécurité - Mycologie – Réactif Yeasto

Urgent safety notice regarding potential contamination of Yeastone Broth affecting laboratories.

Primary source: Téléchargez le courrier de la société Thermo Fisher Scientific (31/08/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

ANSM issued a safety notice stating immediate product recall and actions for laboratories regarding Yeastone Broth (Lot 4539334) due to contamination risks.

Why it matters

The contamination could potentially lead to false positive results in clinical tests, affecting patient safety, especially for those with identified mycosis.

Action needed

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 31, 2026

Full briefing

Practical implication

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

ANSM has issued an urgent safety notification regarding the Yeastone Broth (Lot 4539334), indicating risk of contamination with a Sphingomonas species. Immediate actions are required from laboratories using this product.

What changed: ANSM issued a safety notice stating immediate product recall and actions for laboratories regarding Yeastone Broth (Lot 4539334) due to contamination risks.

Why it matters: The contamination could potentially lead to false positive results in clinical tests, affecting patient safety, especially for those with identified mycosis.

Practical implication: Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-08-31T00:00:00.000Z
  • Discovered by monitor: 2026-08-31T21:32:57.867Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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