medical Class II Updated 2019-10-23

Vital Scientific N.V. recalls Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
View official government recall

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