Z-2362-2023Class II

Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070...

Name: Z-2362-2023 Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070...
Creator: Randox Laboratories Ltd.
Published: 2023-06-13
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-06-13 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena) on 2023-06-13. FDA classified it as Class II and gives the reason as "Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2362-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-13
Posted: 2023-08-09
Recalling firm: Randox Laboratories, Limited
Product: Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Product code: CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Reason for recall: Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
FDA root cause: Under Investigation by firm
Action: RANDOX Distributors issued Medical Device Correction Letter (REC673) on June 13, 2023 to US and PR 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 organisation
Quantity in commerce: 37 US 194 PR
Distribution: US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
Product codes and lots: Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2362-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2362-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-09

Product code CDQ

K923506Class IIUrea KitRandox Laboratories, Ltd. / cleared 1993-09-27

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)