Recall – Automated clinical chemistry system inoperable due to software malfunction

Company: ELITech Group B.V.
Date of Enforcement Report: 10/9/2019
Class III

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.

  • Recall Number: Z-2764-2019

REASON

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

RECALLING FIRM/MANUFACTURER

ELITech Group B.V. on 9/30/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

89 units

DISTRIBUTION

US Nationwide

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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