Reported Aug 16, 2023 · Ongoing
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
(2) | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 |
(3) | UR3873 |
(4) | UR8334 |
- Lot codes and dates
- Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.
- Amount recalled
- 37 US 194 PR
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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