Reported Oct 23, 2019 · Terminated

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

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?

    • Viva-E
    • Catalog # 6002-380
    • UDI # 03661540600050
  • Product Usageautomated chemistry analyzer intended for clinical use
Lot codes and dates
  • serial numbers
    • 10-4582 till 10-4584
    • 10-4586 till 10-4594
    • 11-2309
    • 11-2320 t through 11-2328
    • 11-2330 through-2334
    • 11-2336 through 11-2375
    • 11-2383
    • 11-2384
    • 11-2388
    • 11-2395
    • 12-2314
    • 12-2315
    • 12-2324 12-2325
Amount recalled
75 units

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, 4:48 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.