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Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340
Recalled February 14, 2024 · FDA recall Z-0992-2024 · Randox Laboratories
Hazard
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results. · FDA Class II
Units
3,053 kits (2 US, 3,051 OUS)
Sold at
US Nationwide distribution in the states of SC and OK.
Description
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
Product
RX Series Copper (Cu) Assay Ref. Number CU2340
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →