Quality & complianceOfficial

BfArM publishes EKF-diagnostic field safety notice for Biosen Glucose/Lactate hemolyzing solution

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

The German regulator has posted an urgent field safety notice from EKF-diagnostic GmbH on a reagent for Biosen analysers; the details sit in the manufacturer's attached advisory.

BfArM, Germany's federal medicines and medical devices authority, has published an Urgent Field Safety Notice from EKF-diagnostic GmbH covering the company's Biosen Glucose/Lactate hemolyzing solution. The entry is dated 28 October 2026 and carries reference 49354/26.

The product is listed under in-vitro diagnostics, in the group of equipment and products for clinical chemistry. According to the summary on file, the solution is a reagent used with Biosen analysers.

The BfArM page does not describe the defect or the reason for the notice. It also does not name the affected lots or set out what users must do. It refers readers to the manufacturer's Advisory Notice, attached as a 549 KB PDF.

Until the advisory has been read, the scope of the issue and any corrective actions cannot be assessed from the regulator's listing alone.

What it means for your team

  • Laboratories and distributors using Biosen analysers with this hemolyzing solution should obtain and read the manufacturer's Advisory Notice, reference 49354/26, without delay.
  • Quality teams should check whether any affected lots are held in stock or in use, once the advisory identifies them, and document the actions taken.
  • Regulatory and vigilance staff should note that the BfArM listing gives no defect, lot or action details, so internal assessments must rely on 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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