Reported Oct 23, 2019 · Terminated

Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product…

Vital Scientific N.V.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vital Scientific N.V. · 24, Kanaalweg · Dieren, N/A · N/A

Is this the product you have?

  • Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401
  • Product Usage:clinical chemistry system intended for use in clinical laboratories
Lot codes and dates
  • serial numbers
    • 11-7425
    • 11-7516
    • 11-7535
    • 11-7563
    • 11-7564
Amount recalled
5 instruments

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 19, 2024 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.