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Vital Scientific N.V. recalls V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated ch
Recalled October 2, 2019 · FDA recall Z-2558-2019 · Vital Scientific N.V
Hazard
Instrument stopped working due to a software lockup, and no patient results are produced. · FDA Class II
Units
2
Sold at
US in the state of New York.
Description
Instrument stopped working due to a software lockup, and no patient results are produced.
Product
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.
Manufacturer(s)
Vital Scientific N.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →