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ELITech Group B.V. recalls Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is
Recalled October 9, 2019 · FDA recall Z-2764-2019 · ELITech Group B.V
Hazard
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. · FDA Class III
Units
89 units
Sold at
US Nationwide distribution including the state of NY.
Description
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Product
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.
Manufacturer(s)
ELITech Group B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →