FDA-Device2019-10-23Class II
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
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
5 instruments
Manufactured in
24, Kanaalweg, Postbus 100, Dieren, N/A, Netherlands
Products
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0157-2020Don't want to check this manually?
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