Reported Dec 4, 2019 · Ongoing

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

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
    • REF 6002-800 or 6002-850
    • SN 18-3304
    • IVD
    • (01)03661540600180
Lot codes and dates
  • (OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037
Amount recalled
732 instruments

Where it was sold

Why it was recalled

During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.

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, 6:16 PM UTC

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