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Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and
Recalled May 15, 2024 · FDA recall Z-1786-2024 · Randox Laboratories
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. · FDA Class III
Units
40 units
Sold at
US Nationwide distribution.
Description
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.
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
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →