---
title: "RX Series Copper (Cu) Assay Ref. Number CU2340 — FDA record Z-0992-2024 | Is It on Recall"
description: "Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein,"
url: https://isitonrecall.com/recall/fda-device-z-0992-2024-rx-series-copper-cu-assay-ref-number-cu2340/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# RX Series Copper (Cu) Assay Ref. Number CU2340 — FDA record Z-0992-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: RX Series Copper (Cu) Assay Ref. Number CU2340
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Randox Laboratories Ltd.
- **Quantity**: 3,053 kits (2 US, 3,051 OUS)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0992-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0992-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Nationwide distribution in the states of SC and OK.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
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- [Utah](https://isitonrecall.com/state/utah/)
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- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Feb 14, 2024
- **Recall initiation date**: Nov 29, 2023
- **Center classification date**: Feb 6, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0992-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Randox Laboratories Ltd. records](https://isitonrecall.com/brand/randox-laboratories-ltd/)