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All product recalls associated with Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
Total Recalls
25
Past Year
0
Class I (Serious)
0
Most Recent
Jun 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Cystatin C Reagent marketed without a 510 (k)
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.
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.