Randox Liquid Urine Control Level 2- intended for in vitro diagnostic… — Class II medical device recall Z-2446-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-08-30, distributed nationwide. (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negat
| Recall number | Z-2446-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2023-06-21 |
| Classified | 2023-08-23 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 39 units |
| UPC / GTIN / UDI-DI | 05055273207569 |
| Lot numbers | 1209UC |
| Model numbers | UC5074 |
| Expiration dates | 2024-03-28 |
Product
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
Reason for recall
(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
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-2446-2023. 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.