Quality & complianceOfficial

Siemens Healthineers: Atellica CH Apolipoprotein B lot 252670 fails precision specification

🇳🇱 IGJ · Tue 03 Nov 2026

Complaint investigations confirmed the reagent lot exceeds the within-lab imprecision limit of 7.0% CV on Atellica CH and CI analysers, according to a Dutch inspectorate listing.

Siemens Healthineers has confirmed that Atellica CH Apolipoprotein B (APO B) lot 252670 does not meet its within-lab precision specification of no more than 7.0% coefficient of variation (CV). The finding comes from the company's investigation of customer complaints, as set out in a manufacturer warning listed by the Dutch healthcare inspectorate, IGJ.

The issue applies when the reagent is used on the Atellica CH and Atellica CI analysers. The manufacturer is Siemens Healthcare Diagnostics Inc, with Siemens Healthcare Diagnostics Manufacturing Ltd named as its authorised representative. The field safety notice (FSN) is dated 9 October 2026, and the IGJ warning is dated 4 November 2026.

The IGJ page links to a two-page English-language PDF of the notice. The text available to VigiEye does not set out the specific conditions affecting the lot, any clinical risk assessment, or the corrective actions requested of users, so laboratories should consult the full FSN for those details.

As general context, manufacturers of medical devices, including in vitro diagnostics, must monitor products after they reach the market and act where a risk to users is identified. They inform users and the competent authorities through a field safety notice.

What it means for your team

  • Laboratories using Atellica CH APO B should check whether lot 252670 is in stock or in use and read the full FSN for required actions.
  • Quality teams may wish to review recent APO B quality-control and patient-result data against the 7.0% CV specification, in line with the notice's instructions.
  • Regulatory and vigilance staff should note the FSN date (9 October 2026) and the IGJ listing date (4 November 2026) when tracking the action.
  • The summary text does not state the corrective actions, so teams should not assume them without consulting the notice.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

More Quality & compliance All →