Medical Device Recall: RX Series Copper (Cu) Assay Ref. Number CU2340
Randox Laboratories Ltd. · November 29, 2023
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of SC and OK.
States Affected
NATIONWIDE
Quantity Affected
3,053 kits (2 US, 3,051 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0992-2024
Status: ongoing
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