Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Viva-ProE Systems Recalled by ELITech Group B.V. Due to Software malfunction; The action being taken due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ELITech Group B.V. directly.
Affected 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.
Quantity: 89 units
Why Was This Recalled?
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ELITech Group B.V.
ELITech Group B.V. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report