Reported Oct 2, 2019 · Ongoing

V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated…

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

Is this the product you have?

  • V-Twin, Model # 6002-800
  • UDI03661540600180
  • Product UsageAn in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring
Lot codes and dates
  • Serial #s: 13-3341 and 13-3344
Amount recalled
2

Where it was sold

Why it was recalled

Instrument stopped working due to a software lockup, 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

Data as of Sep 19, 5:37 PM UTC

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