Recall archive / FDA device enforcement
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena) — FDA record Z-2362-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 37 US 194 PR
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2362-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 16, 2023
- Recall initiation date
- Jun 13, 2023
- Center classification date
- Aug 9, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.