Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk
FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a confirmed systematic error (negative bias up to 11%) in a diagnostic test that poses risk of clinical harm through inaccurate results. Qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Randox Laboratories Ltd. recalled its RX Series Urea Enzymatic Kinetic Assay (reference numbers UR3825, UR3873, UR8334, and UR8070 Modena) following discovery of a carryover issue during normal instrument operation. The FDA classified this as a Class II recall.
The problem occurs when a urea assay runs immediately after a Direct LDL-cholesterol assay on the same instrument. Chemical residue from the LDL test carries into the urea test, causing urea results to read abnormally low—up to 11% below the correct value. This bias affects both quality control samples and patient test results, and may lead to delayed result reporting or falsely decreased urea readings that could go unnoticed by laboratory staff.
Affected facilities in the United States include those in California, District of Columbia, Georgia, Ohio, Oklahoma, Minnesota, Missouri, New Jersey, and Virginia, as well as Puerto Rico. Approximately 37 units were distributed in the continental US and 194 in Puerto Rico.
Healthcare providers using these instruments should review their urea test results, particularly those performed immediately after LDL-cholesterol assays, to identify any results that may have been affected by carryover. Contact Randox Laboratories for guidance on corrective actions, which may include repeat testing or instrument recalibration.
The recalled product
- Product
- Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
- Manufacturer
- Randox Laboratories Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalogue Number/GTIN (1) UR3825 05055273206906
- (2) UR3873 05055273206913
- (3) UR8334 05055273209600
- (4) UR8070 05055273209594. Not Batch Specific.
Distribution
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