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BfArM publishes QuidelOrtho field safety notice for VITROS A1c Slides

🇩🇪 BfArM field safety notices · Fri 13 Nov 2026

Germany's BfArM has posted an Urgent Field Safety Notice from QuidelOrtho covering VITROS Chemistry Products A1c Slides, but the listing itself gives no details of the issue.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 13 November 2026 concerning VITROS Chemistry Products A1c Slides. The manufacturer is named as QuidelOrtho, with Ortho Clinical Diagnostics Inc given as the company behind the product.

BfArM files the notice under in-vitro diagnostics, specifically equipment and products for clinical chemistry, with the reference number 49153/26. The A1c Slides are used for HbA1c testing.

The BfArM listing does not describe the nature of the problem, the affected lots or the actions users are asked to take. It refers readers to the manufacturer's Advisory Notice, which is attached as a 710 KB PDF. BfArM marks the file as not meeting its accessibility standards.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action on a marketed device. National authorities such as BfArM then make these notices publicly available.

What it means for your team

  • Laboratories using VITROS A1c Slides should read the full Advisory Notice from QuidelOrtho to establish whether their lots and workflows are affected and what action is needed.
  • Quality and vigilance teams should log reference 49153/26 and confirm that the manufacturer's notice has been received, assessed and acknowledged internally.
  • The BfArM listing alone does not support conclusions about the cause, severity or scope, so no assessment should rely on it without the manufacturer's document.

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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