RX Series Copper (Cu) Assay Ref. Number CU2340
This recall is currently active, issued February 6, 2024. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- November 29, 2023
- Posted
- February 6, 2024
- Recall Number
- Z-0992-2024
- Quantity
- 3,053 kits (2 US, 3,051 OUS)
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
Root Cause
Component design/selection
Action Taken
RANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.