Class III

Medical Device Recall: 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

Randox Laboratories Ltd. · April 5, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

40 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1786-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Randox Laboratories Ltd. Medical Device Recall: 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 | SafeCheck