UREA recallZ-2362-2023 · Randox Laboratories Ltd. · initiated Jun 13, 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
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 category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-2362-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 13, 2023
- Posted by the FDA
- Aug 9, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 37 US 194 PR
- Product code
- CDQ
- FDA submissions
- K923506
- Distribution
- US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
Product description
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Code information (models, lots, serial numbers)
Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- UREA UR3825Randox Laboratories Limited · Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UREA UR3873Randox Laboratories Limited · Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
- UREA UR8334Randox Laboratories Limited · Urease And Glutamic Dehydrogenase, Urea Nitrogen1 recall0 reports
Product lines
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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