# FDA recall Z-2753-2020

> **RANDOX LABORATORIES, LTD.** · Class II · device recall initiated 2020-06-26.

## Product

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

## Reason for recall

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.

## Key facts

- **Recall number:** Z-2753-2020
- **Recalling firm:** RANDOX LABORATORIES, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-12
- **Termination date:** 2020-10-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2020

## Citation

> AI Analytics. FDA recall Z-2753-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2753-2020. Source: US FDA. Licensed CC0.

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