Recall Z-0992-2024 ยท JKZ Diethyldithiocarbamate (Colorimetric), Copper
Randox Laboratories Ltd.
RX Series Copper (Cu) Assay Ref. Number CU2340
| Date | Feb 6, 2024 (initiated Nov 29, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 3,053 kits (2 US, 3,051 OUS) |
| Distribution | US Nationwide distribution in the states of SC and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.