# FDA recall Z-1786-2024

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2024-04-05.

## Product

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination  of parent drug molecule and metabolites of drugs in human urine  Catalog Number: EV4115

## Reason for recall

Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1786-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-05
- **Report date:** 2024-05-15

- **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-1786-2024

## Citation

> AI Analytics. FDA recall Z-1786-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1786-2024. Source: US FDA. Licensed CC0.

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