# FDA recall Z-2446-2023

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-06-21.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.

## Key facts

- **Recall number:** Z-2446-2023
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-21
- **Report date:** 2023-08-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2023

## Citation

> AI Analytics. FDA recall Z-2446-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2446-2023. Source: US FDA. Licensed CC0.

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