# FDA recall Z-2609-2023

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-08-03.

## Product

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

## Reason for recall

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

## Distribution

US States: GA, OH, OR, PA, TX, VA

## Key facts

- **Recall number:** Z-2609-2023
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-03
- **Report date:** 2023-09-27

- **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-2609-2023

## Citation

> AI Analytics. FDA recall Z-2609-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2609-2023. Source: US FDA. Licensed CC0.

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