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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.