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U.S. Department of Health and Human Services

Class 2 Device Recall Randox RX Series Urea Enzymatic Kinetic Assay

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  Class 2 Device Recall Randox RX Series Urea Enzymatic Kinetic Assay see related information
Date Initiated by Firm June 13, 2023
Date Posted August 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-2362-2023
Recall Event ID 92650
510(K)Number K923506  
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
Product Randox RX Series Urea Enzymatic Kinetic Assay
Ref. Numbers:
(1) UR3825
(2) UR3873
(3) UR8334
(4) UR8070 (Modena)
Code Information Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer 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 2		 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 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
Quantity in Commerce 37 US 194 PR
Distribution US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CDQ and Original Applicant = RANDOX LABORATORIES, LTD.
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