RX Series Copper (Cu) Assay Ref. Number CU2340 recallZ-0992-2024 · Randox Laboratories Ltd. · initiated Nov 29, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

RANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.

Recall details

Recall number: Z-0992-2024
Status: Open, Classified
Initiated by the company: Nov 29, 2023
Posted by the FDA: Feb 6, 2024
Recalling firm: Randox Laboratories Ltd.
Quantity: 3,053 kits (2 US, 3,051 OUS)
Product code: JKZ
Distribution: US Nationwide distribution in the states of SC and OK.

Product description

RX Series Copper (Cu) Assay Ref. Number CU2340

Code information (models, lots, serial numbers)

Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

COPPER (Cu) CU2340
Randox Laboratories Limited · Diethyldithiocarbamate (Colorimetric), Copper
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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