# FDA recall Z-0992-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2023-11-29.

## Product

RX Series Copper (Cu) Assay Ref. Number CU2340

## Reason for recall

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order.  If copper assay is run after total protein it could lead to falsely elevated copper results.

## Distribution

US Nationwide distribution in the states of SC and OK.

## Key facts

- **Recall number:** Z-0992-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-29
- **Report date:** 2024-02-14

- **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-0992-2024

## Citation

> AI Analytics. FDA recall Z-0992-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0992-2024. Source: US FDA. Licensed CC0.

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