Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and…

Recall date

April 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1786-2024

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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