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-TwinREF 6002-800 or 6002-850SN 18-3304IVD(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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