# FDA recall Z-2059-2018

> **Randox Laboratories** · Class II · device recall initiated 2018-05-04.

## Product

RX Imola (RX4900)    For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

## Reason for recall

Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

## Distribution

US Distribution including Puerto Rico and the state of : West Virginia.

## Key facts

- **Recall number:** Z-2059-2018
- **Recalling firm:** Randox Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-04
- **Report date:** 2018-06-13
- **Termination date:** 2020-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kearneysville, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2018

## Citation

> AI Analytics. FDA recall Z-2059-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2059-2018. Source: US FDA. Licensed CC0.

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