FDA Device recall Z-0992-2024
RX Series Copper (Cu) Assay Ref
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of RX Series Copper (Cu) Assay Ref by Randox Laboratories, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0992-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-29 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
RX Series Copper (Cu) Assay Ref. Number CU2340
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.
Identifiers
| code_info | Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2024%22
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