Quality & complianceOfficial

BfArM publishes field safety notice for Applied Biosystems Diomni Software from Life Technologies

🇩🇪 BfArM field safety notices · Thu 22 Oct 2026

Germany's medicines and devices authority has posted a manufacturer advisory covering the Diomni Software, an in-vitro diagnostic product, though the published listing does not describe the underlying issue.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Life Technologies Holdings Pte Ltd concerning its Applied Biosystems Diomni Software. The listing is dated 22 October 2026 and carries the reference 42982/26.

BfArM classes the item under in-vitro diagnostics, specifically instruments, apparatuses and systems. The web entry itself gives no description of the problem, the affected versions or the corrective steps. It directs readers to the manufacturer's Advisory Notice, attached as a PDF of about 295 KB.

Because the notice text was not reproduced in the BfArM listing, it is not possible to say what prompted the action, whether any patient or user harm has been reported, or what users are being asked to do. Those details are only in the manufacturer's attachment.

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 medical device. Competent authorities such as BfArM make these notices publicly available.

What it means for your team

  • Laboratories and organisations using Applied Biosystems Diomni Software should read the full Advisory Notice attached to BfArM reference 42982/26 to establish whether they are affected and what action is needed.
  • Quality and regulatory teams should check that the notice is logged in their field action and vigilance records, and that any required response to the manufacturer is tracked.
  • No details of the issue or required actions appear in the BfArM listing, so conclusions should not be drawn until the manufacturer's document has been reviewed.

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.

More Quality & compliance All →