Lower riskMedical device recall · FDA · Published June 13, 2023
Randox RX Urea Assay Kits May Give False Low Results - Recall
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 RX Urea Assay Kits May Give False Low Results - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57853-randox-rx-urea-assay-kits-may-give-false-low-results. Based on FDA recall #Z-2362-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2023%22&limit=1).
The FDA announced on June 13, 2023, that Randox Laboratories Ltd. is recalling its RX Series Urea Enzymatic Kinetic Assay due to potential negative bias in test results. The agency classified the recall as Class II.
Distribution: US Nationwide in CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico
The hazard
According to the FDA, carryover from the Direct LDL-cholesterol assay on Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples if the urea assay is run immediately after. This may lead to a delay in reporting results or in falsely decreased urea test results.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include the June 7, 2024, Randox Cystatin C Reagent Recall for missing FDA 510(k) and the April 5, 2024, Randox Evidence MultiSTAT Software v3.7 Recall for light leak risk. Other recent recalls of similar products include the July 6, 2026, Siemens Atellica CH Urine Albumin Recall: False Results Risk and the Jan. 20, 2026, Siemens Atellica CH Urine Albumin Recall: False Low Results Risk.
How to tell if you have this one
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.
Brand
Randox
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Look for the model number on the kit label to see if it matches UR3825, UR3873, UR8334, or UR8070 (Modena).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Georgia, Minnesota, Missouri, New Jersey, Ohio, Oklahoma, Puerto Rico, Virginia.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2362-2023 (June 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2362-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.