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BfArM publishes Inova Diagnostics field safety notice for Aptiva CTD Essential Reagent

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

Germany's medicines and devices authority has listed an urgent field safety notice for an Inova in vitro diagnostic reagent, with the details contained only in the manufacturer's advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Inova Diagnostics, Inc. relating to its Aptiva CTD Essential Reagent. The entry is dated 28 October 2026 and carries the reference 47859/26.

BfArM classifies the product under in vitro diagnostics, specifically equipment and products for clinical chemistry. The authority's web entry is brief and does not describe the problem with the reagent, the lots concerned or the steps users are asked to take.

Instead, BfArM refers readers to the manufacturer's Advisory Notice, which is attached to the entry as a PDF of about 1 MB. Those details, including the nature of the issue and any corrective action, are therefore available only in that document.

As general context, a field safety notice is the communication a manufacturer sends to customers when it takes a field safety corrective action for a medical device, and national authorities such as BfArM commonly make these notices public.

What it means for your team

  • Laboratories using the Aptiva CTD Essential Reagent should obtain and read the full Inova Advisory Notice to establish whether their stock is affected.
  • Quality and regulatory teams should record receipt of the notice under reference 47859/26 and follow their usual field safety corrective action procedures.
  • The BfArM listing gives no information on the defect, affected lots or required actions, so no conclusions about risk should be drawn from it 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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