Device product
RX Series Copper (Cu) Assay Ref. Number CU2340
Z-0992-2024
Product summary
- Event
- Event 93775
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,053 kits (2 US, 3,051 OUS)
- Official record key
device-enforcement:Z-0992-2024
Official wording
Reason: 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.
Code information: Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
Distribution pattern: US Nationwide distribution in the states of SC and OK.
Derived failure modes
-
Unknown
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.