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BfArM publishes Trinity Biotech field safety notice for Oxalate Reagent B and kit

🇩🇪 BfArM field safety notices · Wed 21 Oct 2026

Germany's medicines and devices regulator has listed an urgent field safety notice from Trinity Biotech covering an oxalate reagent and the kit that contains it, with details in the manufacturer's advisory.

The Federal Institute for Drugs and Medical Devices (BfArM) has published an Urgent Field Safety Notice from Trinity Biotech Plc concerning Oxalate Reagent B and the Oxalate Kit that contains it. The entry is dated 21 October 2026 and carries the reference 39318/26.

BfArM classifies the products under in vitro diagnostics, specifically equipment and products for clinical chemistry. The regulator's listing does not describe the problem, name the affected lots or set out what users must do.

Those details are in the manufacturer's Advisory Notice, which BfArM has attached to the entry as a PDF of about 1MB. The regulator directs readers to that document for further information on the device.

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 device already on the market. National authorities such as BfArM often publish these notices on their websites.

What it means for your team

  • Laboratories using Trinity Biotech's Oxalate Reagent B or the Oxalate Kit should obtain and read the full Advisory Notice to check whether their stock is affected.
  • Quality teams should not rely on the BfArM listing alone, since it gives no defect description, lot numbers or corrective actions.
  • Regulatory and vigilance staff may wish to log reference 39318/26 and confirm that any actions required in the manufacturer's notice are documented.

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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