PV Bulletin

QIAstat-Dx Gastrointestinal Panel 2 – Qiagen Safety Information

Safety information regarding the QIAstat-Dx Gastrointestinal Panel 2 has been issued by ANSM, highlighting safety actions and a recall.

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

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

ANSM announced a safety action with registration number R2626013 regarding a product recall for QIAstat-Dx Gastrointestinal Panel 2 (Recall No. R2624620), as of September 9, 2026.

Why it matters

This safety information is crucial for healthcare providers and laboratories utilizing the QIAstat-Dx Gastrointestinal Panel 2 to ensure patient safety and compliance with the recall process.

Action needed

Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.

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 9, 2026

Full briefing

Practical implication

Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.

The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued safety information regarding the QIAstat-Dx Gastrointestinal Panel 2, including some significant actions linked to a product recall due to identified safety concerns.

What changed: ANSM announced a safety action with registration number R2626013 regarding a product recall for QIAstat-Dx Gastrointestinal Panel 2 (Recall No. R2624620), as of September 9, 2026.

Why it matters: This safety information is crucial for healthcare providers and laboratories utilizing the QIAstat-Dx Gastrointestinal Panel 2 to ensure patient safety and compliance with the recall process.

Practical implication: Healthcare providers and laboratories must adhere to the recall notification and ensure the withdrawal of the affected lot of the QIAstat-Dx Gastrointestinal Panel 2.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-09T00:00:00.000Z
  • Discovered by monitor: 2026-09-09T21:45:29.780Z

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

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