Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.

Randox Laboratories Ltd UK notified the US Distributor Randox Laboratories via email on 4/05/ 24. End-Users notified by email on 4/9/24. Letter (REC736) states reason for recall, health risk and action to take: " Export support files for the last 10 samples run and share with Randox using the link to be provided " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. " Affected chip heater assembly replacement to be arranged by Randox Service Engineer Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation