ELITech Group B.V. recalls Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is…

Recall date

July 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2764-2019

FDA classification

Class III

Brand / firm

ELITech Group B.V.

Sold / distributed

US Nationwide distribution including the state of NY.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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 spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.