Reported Oct 16, 2019 · Terminated
V-Twin, Catalog # 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 · N/A
Is this the product you have?
- V-Twin, Catalog # 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
- The following serial numbers
14-3301-14-334415-3301-15-332616-3301 -16-335317-3301 -17-334618-3301-18-3323
- The following serial numbers
- Amount recalled
- 192 devices
Where it was sold
- Nationwide
- NY
Why it was recalled
The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
This product could cause temporary or reversible health problems — stop using it.
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