FDA-Device2019-10-09Class III
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,
ELITech Group B.V.
Hazard
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Sold states
US Nationwide distribution including the state of NY.
Affected count
89 units
Manufactured in
Van Rensselaerweg 4, N/A, Spankeren, N/A, Netherlands
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2764-2019Don't want to check this manually?
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