FDA recall Z-2558-2019

Vital Scientific N.V. · Class II · device

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.

Reason for recall

Instrument stopped working due to a software lockup, and no patient results are produced.

Distribution

US in the state of New York.

Key facts

Status
Ongoing
Initiation date
2016-01-18
Report date
2019-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dieren, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2019