# FDA recall Z-1631-2018

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2018-03-02.

## Product

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284    Product Usage:  For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

## Reason for recall

Randox  has now released further steps to avoid contamination of the Lipase Assay on Rx  instruments.

## Distribution

US Nationwide Distribution in the states of West Virginia and Puerto Rico

## Key facts

- **Recall number:** Z-1631-2018
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-02
- **Report date:** 2018-05-16
- **Termination date:** 2019-04-11

- **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-1631-2018

## Citation

> AI Analytics. FDA recall Z-1631-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1631-2018. Source: US FDA. Licensed CC0.

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