FDA Device recall Z-2362-2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of Randox RX Series Urea Enzymatic Kinetic Assay Ref by Randox Laboratories, citing carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2362-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-13 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Reason
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
Identifiers
| code_info | Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2023%22
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