FDA-Device2023-08-16Class II
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Randox Laboratories Ltd.
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
Affected count
37 US 194 PR
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2023Don't want to check this manually?
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