FDAJuly 12, 2016device

Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophoto...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

What to do

FDA enforcement status: Terminated

Brands named

elitech group b velitechelitech group

UPCs

03661540600357

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophoto... — Recall Details · AllClear