# FDA recall Z-1106-2019

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2019-02-07.

## Product

Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112    Product Usage:  This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

## Reason for recall

The target value for uptake is incorrect on the value sheet for an analyzer.  The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

## Distribution

The products were distributed to the following US states: WV and Puerto Rico.

## Key facts

- **Recall number:** Z-1106-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-07
- **Report date:** 2019-04-17
- **Termination date:** 2020-06-08

- **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-1106-2019

## Citation

> AI Analytics. FDA recall Z-1106-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1106-2019. Source: US FDA. Licensed CC0.

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