Randox Laboratories is recalling 3,053 RX Series Copper (Cu) Assay kits (Ref. Number CU2340) used in laboratory settings on RX series instruments. The recall was initiated because the copper assay can produce falsely elevated results if it is run immediately after a Total Protein test on the instrument's testing order. This error occurred due to an outdated technical bulletin regarding carryover avoidance between different chemical tests. While 3,051 units were distributed internationally, two units were sold in South Carolina and Oklahoma. Patients should discuss any unusual lab results with their healthcare providers.
The defect causes the instrument to carry over materials from a Total Protein test into a Copper test, resulting in a falsely high copper reading. This could lead doctors to misdiagnose conditions or provide incorrect treatments based on inaccurate laboratory data.
Technical Bulletin Update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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