Randox Laboratories Ltd. Recall 92650
Description: Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Randox Laboratories Ltd. Recall 92650 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2362-2023 |
| Event ID | 92650 |
| Event Description | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico. |
| Quantity | 37 US 194 PR |
| Recall 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. |
| Device Classification | 20230816 |
| Device Code Info | Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific. |
| Center Classification Date | 20230809 |
| Recall Initiation Date | 20230613 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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