Reported Oct 23, 2019 · Terminated

V-Twin, Catalog # 6002-800, UDI # 03661540600180 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?

    • V-Twin
    • Catalog # 6002-800
    • UDI # 03661540600180
  • Product Usageautomated chemistry analyzer intended for clinical use
Lot codes and dates
  • serial numbers
    • 10-3331
    • 10-3332
    • 11-3301
    • 11-3304 through 11-3306
    • 11-3308 through 11-3312
    • 11-3315
    • 11-3316
    • 11-3318 through 11-3342
    • 12-3302
Amount recalled
39 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, 4:49 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.