PV Bulletin

ANSM (France) - Safety information feed: Auto-immunité – Réactif Anti-Annexin V IgG – Orgentec sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information de sécurité - Auto-immunité – Réactif Anti-Annexin - A

Important safety information regarding the Anti-Annexin V IgG diagnostic reagent by Orgentec due to a labeling error.

Primary source: Téléchargez le courrier de la société Orgentec (10/09/2026)

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

A corrective safety action was implemented due to mislabeling of test strips from lot number 2605614. Some strips were incorrectly labeled as 'Anti-Gliadine IgG' instead of 'Anti-Annexin V IgG'.

Why it matters

Mislabeling may lead to incorrect test results, posing risks to patients undergoing diagnostic procedures related to auto-immune conditions.

Action needed

Laboratories must quarantine and verify impacted lots immediately, and respond to the safety notice within 5 working days.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal ManagementVendor OversightCAPA
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 10, 2026

Full briefing

Practical implication

Laboratories must quarantine and verify impacted lots immediately, and respond to the safety notice within 5 working days.

The ANSM (France) issued a Field Safety Notice concerning the Anti-Annexin V IgG (product code ORG 243G, lot number 2605614) due to mislabeling on certain test strips, which could lead to incorrect test results. Immediate corrective actions are required by users and laboratories.

What changed: A corrective safety action was implemented due to mislabeling of test strips from lot number 2605614. Some strips were incorrectly labeled as 'Anti-Gliadine IgG' instead of 'Anti-Annexin V IgG'.

Why it matters: Mislabeling may lead to incorrect test results, posing risks to patients undergoing diagnostic procedures related to auto-immune conditions.

Practical implication: Laboratories must quarantine and verify impacted lots immediately, and respond to the safety notice within 5 working days.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:36.018Z

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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