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Siemens Healthcare Diagnostics issues urgent field safety notice for Atellica CH Apolipoprotein B assay

🇩🇪 BfArM field safety notices · Mon 02 Nov 2026

BfArM has published a manufacturer field safety notice for the Atellica CH APO B assay, but the issue, affected lots and user actions appear only in an attached advisory.

The German federal institute BfArM has published an Urgent Field Safety Notice from Siemens Healthcare Diagnostics Inc., Tarrytown, concerning the Atellica CH Apolipoprotein B (APO B) assay. The entry is dated 2 November 2026 and carries reference 46612/26.

BfArM lists the product group as in-vitro diagnostics, immunological products. The source text does not describe the nature of the problem, the lots or software versions affected, or the risk to patient results.

Those details are contained only in the manufacturer's Advisory Notice, supplied as a 734 KB PDF attached to the BfArM listing. That document was not available for this report, so the reason for the notice and any required corrective steps cannot be stated here. (The BfArM entry spells the product name as "Attelica" in its title; the product is given here as Atellica.)

As general context, a field safety notice is the means by which a manufacturer informs users of a safety-related action on a marketed device, and regulators such as BfArM make these notices publicly available.

What it means for your team

  • Laboratories using the Atellica CH APO B assay should obtain and read the manufacturer's full Advisory Notice via the BfArM listing or from Siemens Healthcare Diagnostics.
  • Quality and vigilance teams should check whether their instruments, reagents or lots fall within the scope of the notice before deciding on any corrective action.
  • Until the advisory is reviewed, the nature and severity of the issue remain unknown; no conclusions about result reliability should be drawn from the BfArM entry alone.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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