Randox Urinalysis Control Level 2 — Class III medical device recall Z-2557-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-10-02, distributed nationwide. Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected t
| Recall number | Z-2557-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2019-07-25 |
| Classified | 2019-09-23 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2020-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 1 kits |
| Lot numbers | 1020UC |
| Model numbers | UC5034 |
| Expiration dates | 2020-05-28 |
Product
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Reason for recall
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
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-2557-2019. 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.