FDA-Device2019-10-23Class II

Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

Vital Scientific N.V.
Hazard

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

Sold states
US Nationwide in the states of NY, and UT
Affected count
4 units
Manufactured in
24, Kanaalweg, Postbus 100, Dieren, N/A, Netherlands
Products
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0154-2020

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