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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