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

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

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