Recall Z-2362-2023 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
| Date | Aug 9, 2023 (initiated Jun 13, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | RANDOX Distributors issued Medical Device Correction Letter (REC673) on June 13, 2023 to US and PR consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five wor |
| Quantity | 37 US 194 PR |
| Distribution | US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923506 | UREA KIT Randox Laboratories, Ltd., Sep 27, 1993 |