PV Bulletin

Atellica CH Revised C-Reactive Protein (RCRP) Safety Information - Siemens Healthcare Diagnostics

The ANSM has issued safety information regarding the Atellica CH Revised C-Reactive Protein (RCRP) reagent by Siemens Healthcare Diagnostics.

Primary source: Téléchargez le courrier de la société Siemens Healthcare Diagnostics Inc (07/09/2026)

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

The ANSM issued a safety action registration number R2625739 related to the Atellica CH Revised C-Reactive Protein (RCRP), applicable to laboratories performing medical biology analyses.

Why it matters

This alert is essential as it communicates safety concerns and operational changes required for the handling of the Atellica CH RCRP reagent, ensuring the safety and effectiveness of diagnoses made using it.

Action needed

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Relevant for
QPPVMedical 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 7, 2026

Full briefing

Practical implication

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

The French National Agency for the Safety of Medicines and Health Products (ANSM) has published safety information concerning the Atellica CH Revised C-Reactive Protein (RCRP) diagnostic reagent. This information is crucial for laboratories conducting medical biology analyses.

What changed: The ANSM issued a safety action registration number R2625739 related to the Atellica CH Revised C-Reactive Protein (RCRP), applicable to laboratories performing medical biology analyses.

Why it matters: This alert is essential as it communicates safety concerns and operational changes required for the handling of the Atellica CH RCRP reagent, ensuring the safety and effectiveness of diagnoses made using it.

Practical implication: Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-07T00:00:00.000Z
  • Discovered by monitor: 2026-09-07T21:36:51.064Z

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

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of StrykeFlow PS Irrigation/Suction Devices and AHTO Tubing – Stryker

Urgency: High

Clinics and healthcare facilities are required to verify their inventory immediately and isolate any affected units to prevent accidental use.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward