Lower risk Medical device recall · FDA · Published November 29, 2023

Randox RX Series Copper Assay: False High Copper Results Risk

Randox recalls RX Series Copper (Cu) Assay Ref. CU2340 due to risk of falsely elevated copper results when run after total protein tests. Affected units have specific batch numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0992-2024Medical device Randox ›

Lower-risk 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.

Take action

Contact the company

Recalling firmRandox Laboratories Ltd.55 Diamond Road · Crumlin (North), Ireland

✎ GovInfoNow plain-language explainer

Randox is recalling RX Series Copper (Cu) Assay Ref. CU2340 because running this test after total protein tests can cause false high copper results. This affects laboratory users who test samples on these instruments. Read more at govinfonow.com/recall/56732-randox-rx-series-copper-assay-false-high-copper-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56732-randox-rx-series-copper-assay-false-high-copper-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0992-2024

Cite this page

“Randox RX Series Copper Assay: False High Copper Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56732-randox-rx-series-copper-assay-false-high-copper-results-risk. Based on FDA recall #Z-0992-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2024%22&limit=1).

The FDA announced on 2023-11-29 that Randox Laboratories Ltd. is recalling RX Series Copper (Cu) Assay Ref. Number CU2340 due to the risk of falsely elevated copper results. The agency stated that running the assay directly after Total Protein can cause this error.

How to tell if you have it

Brand: Randox
Product: RX Series Copper (Cu) Assay
Ref. Number: CU2340
Catalogue Number/GTIN: CU2340 05055273201949
Lot codes: 592278, 610661, 610669, 629021, 647201, 657944
Quantity: 3,053 kits (2 US, 3,051 OUS)
Distribution: SC and OK

The hazard

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

Context

GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls of similar products include Randox Cystatin C Reagent Recall (2024-06-07), Randox Evidence MultiSTAT Software v3.7 Recall (2024-04-05), and Randox Clinical Chemistry Calibration Serum Recall (2024-03-05). Siemens Atellica CH RCRP Test May Give False High Results was recalled on 2026-08-17.

How to tell if you have this one

Check for the product name 'RX Series Copper (Cu) Assay Ref. Number CU2340' with batch numbers 592278, 610661, 610669, 629021, 647201, or 657944.

Brand
Randox
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your Copper assay has the batch numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of SC and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Oklahoma, South Carolina.

Recall timeline

FDA published this recall 3 months after the firm started it.

Nov 29, 2023Firm started the recall
Feb 6, 2024FDA classified it Class II
Feb 14, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56732-randox-rx-series-copper-assay-false-high-copper-results-risk">Randox RX Series Copper Assay: False High Copper Results Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0992-2024 (November 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0992-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.