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Recall Observatory FDA recall evidence

Device product

Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

Z-2362-2023

June 13, 2023

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 92650
Status
Ongoing
Classification
Class II
Quantity
37 US 194 PR
Official record key
device-enforcement:Z-2362-2023

Official wording

Reason: 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.

Code information: Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.

Distribution pattern: US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.