Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
This recall is currently active, issued August 9, 2023. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- June 13, 2023
- Posted
- August 9, 2023
- Recall Number
- Z-2362-2023
- Quantity
- 37 US 194 PR
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
Lot / Code Info
Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.
Root Cause
Under Investigation by firm
Action Taken
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 working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation