Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Reported: August 16, 2023 Initiated: June 13, 2023 #Z-2362-2023
Product Description
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Reason for Recall
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 37 US 194 PR
- Distribution
- US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena). Recalled by Randox Laboratories Ltd.. Units affected: 37 US 194 PR.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2362-2023.
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