RX Series Copper — Class II medical device recall Z-0992-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-02-14, distributed nationwide. Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Coppe
| Recall number | Z-0992-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2023-11-29 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273201949 |
| Lot numbers | 592278, 610661, 610669, 629021, 647201, 657944 |
| Model numbers | CU2340 |
Product
RX Series Copper (Cu) Assay Ref. Number CU2340
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0992-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.