FDA-Device2024-02-14Class II
RX Series Copper (Cu) Assay Ref. Number CU2340
Randox Laboratories Ltd.
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.
Sold states
US Nationwide distribution in the states of SC and OK.
Affected count
3,053 kits (2 US, 3,051 OUS)
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
RX Series Copper (Cu) Assay Ref. Number CU2340
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2024Don't want to check this manually?
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