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

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
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Urgent Withdrawal of Reusable da Vinci S and Si Instruments Due to Cable Degradation

Urgency: High

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Latest
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Urgent Safety Notification - da Vinci X and Xi Instruments - Intuitive Surgical

Urgency: High

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

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

ANSM (France) - Safety information feed: Trocart à ballonnet structurel Auto Suture et trocart à pointe émoussée Auto Suture de Covidien – Medtronic sur le site de l'Agence nationale de sécurité du médicamentet des produits de santé Information

Urgency: High

Health professionals must ensure adherence to the manufacturer’s instructions when using the affected devices, including appropriate trocar size selection and avoiding excessive force.

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