FDA-Device2019-10-23Class II
Viva-E, Catalog # 6002-380, UDI # 03661540600050 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
75 units
Manufactured in
24, Kanaalweg, Postbus 100, Dieren, N/A, Netherlands
Products
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief