FDA-Device2019-10-02Class II
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An 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.
Vital Scientific N.V.
Hazard
Instrument stopped working due to a software lockup, and no patient results are produced.
Sold states
US in the state of New York.
Affected count
2
Manufactured in
24, Kanaalweg, Postbus 100, Dieren, Netherlands
Products
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2019Don't want to check this manually?
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