# FDA recall Z-1547-2020

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2020-02-18.

## Product

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

## Reason for recall

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE,  and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.

## Key facts

- **Recall number:** Z-1547-2020
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-02-18
- **Report date:** 2020-04-01

- **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-1547-2020

## Citation

> AI Analytics. FDA recall Z-1547-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1547-2020. Source: US FDA. Licensed CC0.

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