Recall Z-2362-2023
Randox Laboratories Ltd. · initiated June 13, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Codes / lots: Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.
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.
FDA-determined 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
Details
- Recall number
- Z-2362-2023
- Initiated
- June 13, 2023
- Posted by FDA
- August 9, 2023
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- 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.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North