# FDA recall Z-0381-2019

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2018-10-02.

## Product

Liquid Cardiac Control, CQ5052

## Reason for recall

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.

## Distribution

Distributed to IN, NY, PR, and WV.

## Key facts

- **Recall number:** Z-0381-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-02
- **Report date:** 2018-11-14
- **Termination date:** 2019-05-30

- **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-0381-2019

## Citation

> AI Analytics. FDA recall Z-0381-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0381-2019. Source: US FDA. Licensed CC0.

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