FDA recall Z-1786-2024

Randox Laboratories Ltd. · Class III · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-04-05
Report date
2024-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2024