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Beckman Coulter issues urgent field safety notice for LabPro V5.0 Maintenance Update 1 software

🇩🇪 BfArM field safety notices · Wed 28 Oct 2026

BfArM has published Beckman Coulter's notice covering LabPro V5.0 Maintenance Update 1 with Panel Update 09, though the issue and required actions are only in the enclosed Advisory Notice.

Germany's federal medical device authority, BfArM, has published an Urgent Field Safety Notice from Beckman Coulter, Inc. on 28 October 2026. It covers LabPro V5.0 Maintenance Update 1 with Panel Update 09, listed in the in-vitro diagnostics category for clinical chemistry equipment and products.

Two product codes are affected. C82964 is the DVD kit version of the update, and C90384 is the electronic version. BfArM lists the notice under reference 48248/26.

The BfArM web entry does not describe the underlying problem, the risk to users or the corrective measures. It points readers to the manufacturer's Advisory Notice, which is attached as a 2 MB PDF. The page flags that the file does not meet accessibility standards.

Field safety notices are issued by manufacturers to inform users of a problem with a marketed device and of the steps they should take. Competent authorities such as BfArM publish them for transparency.

What it means for your team

  • Laboratories using LabPro V5.0 Maintenance Update 1 with Panel Update 09, on DVD or electronic download, should obtain and read the full Advisory Notice from Beckman Coulter or BfArM.
  • Quality and regulatory teams should check whether affected product codes C82964 or C90384 are installed and record the notice under reference 48248/26 in their field action tracking.
  • The nature of the issue and any required user action cannot be determined from the BfArM listing alone, so no assessment of impact should be made 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.

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