Company: Vital Scientific N.V.
Date of Enforcement Report: 10/2/2019
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.
- Recall Number: Z-2558-2019
Instrument stopped working due to a software lockup, and no patient results are produced.
Vital Scientific N.V. on 1/18/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US in the state of New York.