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Vital Scientific N.V. recalls Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product U
Recalled October 23, 2019 · FDA recall Z-0157-2020 · 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. · FDA Class II
Units
5 instruments
Sold at
US Nationwide in the states of NY, and UT
Description
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Product
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.
Manufacturer(s)
Vital Scientific N.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →