FDA-Device2024-05-15Class III
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.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
40 units
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2024Don't want to check this manually?
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