Official recall record
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-13
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05055273206906
- Brand on record
- Randox Laboratories Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-04-05 · US FDA — Medical Devices
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All 7 official recall notices naming Randox Laboratories Ltd. on this site →
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