# FDA recall Z-2557-2019

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2019-07-25.

## 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+.

## Distribution

US Nationwide distribution including the states of IN, WV.

## Key facts

- **Recall number:** Z-2557-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-25
- **Report date:** 2019-10-02
- **Termination date:** 2020-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2019

## Citation

> AI Analytics. FDA recall Z-2557-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2557-2019. Source: US FDA. Licensed CC0.

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