Z-0992-2024Class II

RX Series Copper (Cu) Assay Ref. Number CU2340

Name: Z-0992-2024 RX Series Copper (Cu) Assay Ref. Number CU2340
Creator: Randox Laboratories Ltd.
Published: 2023-11-29
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-11-29 / Open, Classified / root cause: design

FDA source

Randox Laboratories Ltd. began a recall of RX Series Copper (Cu) Assay Ref. Number CU2340 on 2023-11-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0992-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-29
Posted: 2024-02-06
Recalling firm: Randox Laboratories, Limited
Product: RX Series Copper (Cu) Assay Ref. Number CU2340
Product code: JKZ Diethyldithiocarbamate (Colorimetric), Copper
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 3,053 kits (2 US, 3,051 OUS)
Distribution: US Nationwide distribution in the states of SC and OK.
Product codes and lots: Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0992-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code JKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)