Randox recalls specific urea assay kits that may cause false low urea results if used immediately after LDL cholesterol tests, potentially delaying accurate patient results.
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.
Randox is recalling four specific urea assay kits that could produce false low results when run right after LDL cholesterol tests. This might delay proper patient treatment or cause incorrect diagnoses.
The urea assay kits may show falsely low results if run immediately after a LDL cholesterol test on the same instrument. This happens because of carryover from the previous test. False low results could delay proper treatment or cause incorrect diagnoses.
Lab users who run the Randox RX Urea Assay kits (model numbers UR3825, UR3873, UR8334, UR8070) may be affected. Patients receiving results from these kits could have inaccurate urea measurements.
Check if your kit has one of the model numbers: UR3825, UR3873, UR8334, or UR8070 (Modena). These kits were sold with the specific catalog numbers listed in the recall notice.
Look for the model number on the kit label to see if it matches UR3825, UR3873, UR8334, or UR8070 (Modena).
The urea assay kits may show falsely low results if run immediately after a LDL cholesterol test on the same instrument, which could delay treatment or cause incorrect diagnoses.
Check the model number on your kit. If it matches UR3825, UR3873, UR8334, or UR8070 (Modena), you may need to contact Randox for guidance.
No, this recall involves potential inaccurate test results, not physical harm or injury.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2362-2023 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
