FDA Device recall Z-2557-2019
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control…
- FDA Device
- Class III
- terminated
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class III recall of Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control… by Randox Laboratories, citing analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2557-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-25 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | US |
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
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Identifiers
| code_info | Lot: 1020UC Exp. Date: 28 May 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2557-2019%22
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