Vital Scientific N.V. recalls V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemi…

Recall date

January 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2558-2019

FDA classification

Class II

Brand / firm

Vital Scientific N.V.

Sold / distributed

US in the state of New York.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.