PV Bulletin

NADAL® Rota-Adenovirus Test Urgent Safety Notice - Nal Von Minden

Urgent safety notice related to the NADAL® Rota-Adenovirus Test concerning incorrect expiration labeling.

Primary source: Téléchargez le courrier de la société Nal Von Minden (10/09/2026)

Translated From Another Language

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 safety notification was issued on 26 August 2026 (reference FSCA-2026-01) regarding a labeling error in the NADAL® Rota-Adenovirus Test kits.

Why it matters

Stakeholders need to be aware of the labeling correction to prevent confusion regarding the usability of the product, ensuring the integrity of patient testing and safety.

Action needed

Users must acknowledge receipt of the safety notice, and distributors are required to inform all affected users promptly and ensure that the notice reaches all relevant parties.

Relevant for
Regulatory Intelligence LeadMedical Safety Lead
Processes impacted
Signal Management
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

Users must acknowledge receipt of the safety notice, and distributors are required to inform all affected users promptly and ensure that the notice reaches all relevant parties.

An urgent safety notification was issued regarding the NADAL® Rota-Adenovirus Test due to a labeling error on sample collection tubes, which incorrectly indicated an expiration date of 26 February 2026 instead of the correct date, 26 February 2028. The safety of the products is not compromised, and users are advised to read the notice carefully.

What changed: A safety notification was issued on 26 August 2026 (reference FSCA-2026-01) regarding a labeling error in the NADAL® Rota-Adenovirus Test kits.

Why it matters: Stakeholders need to be aware of the labeling correction to prevent confusion regarding the usability of the product, ensuring the integrity of patient testing and safety.

Practical implication: Users must acknowledge receipt of the safety notice, and distributors are required to inform all affected users promptly and ensure that the notice reaches all relevant parties.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-10T00:00:00.000Z
  • Discovered by monitor: 2026-09-10T21:31:36.022Z

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

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

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