FDA recall Z-0155-2020

Vital Scientific N.V. · Class II · device

Product

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Distribution

US Nationwide in the states of NY, and UT

Key facts

Status
Terminated
Initiation date
2012-01-10
Report date
2019-10-23
Termination date
2024-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dieren, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2020