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Terminated

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.

FDA Recall Z-2764-2019 · Posted None

Recalling FirmELITech Group B.V.
Recall StatusTerminated
Product CodeJJE
Date Initiated2016-07-12
Date Terminated2022-02-04
Product Quantity89 units

Reason for Recall

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

Firm Action

Consignees were notified via a non-mandatory upgrade in July 2016

Root Cause

Software design

Distribution Pattern

US Nationwide distribution including the state of NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BV · 2011-03-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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