Medical device recalls Moderate risk

Vital Scientific N.V. recalls Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usa…

Recall date
January 10, 2012
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0157-2020
FDA classification
Class II
Brand / firm
Vital Scientific N.V.
Sold / distributed
US Nationwide in the states of NY, and UT

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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