Recall Z-0992-2024
Randox Laboratories Ltd. · initiated November 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RX Series Copper (Cu) Assay Ref. Number CU2340
Codes / lots: Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
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.
FDA-determined 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.
Details
- Recall number
- Z-0992-2024
- Initiated
- November 29, 2023
- Posted by FDA
- February 6, 2024
- Product code
- JKZ – Diethyldithiocarbamate (Colorimetric), Copper
- Quantity
- 3,053 kits (2 US, 3,051 OUS)
- Distribution
- US Nationwide distribution in the states of SC and OK.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North