# FDA recall Z-0937-2018

> **Randox Laboratories, Limited** · Class II · device recall initiated 2017-08-08.

## Product

Liquid Cardiac Control CQ5053

## Reason for recall

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

## Distribution

Nationally

## Key facts

- **Recall number:** Z-0937-2018
- **Recalling firm:** Randox Laboratories, Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-08
- **Report date:** 2018-03-21
- **Termination date:** 2018-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2018

## Citation

> AI Analytics. FDA recall Z-0937-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0937-2018. Source: US FDA. Licensed CC0.

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