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U.S. Department of Health and Human Services

Class 2 Device Recall Randox

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  Class 2 Device Recall Randox see related information
Date Initiated by Firm November 01, 2022
Date Posted December 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0363-2023
Recall Event ID 91097
510(K)Number K955797  
Product Classification Igm, antigen, antiserum, control - Product Code DFT
Product IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IM3834
Code Information GTIN: 05055273204001 All lots
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Laboratories extended recall notification to the US Distribution center on 11/01/22 via email. The US distributor contacted customers on 11/1/22 via email . 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-0136} " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0136} 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. If you have any questions or concerns, please contact Randox Technical Services
Quantity in Commerce 20 kits US in total
Distribution US Nationwide Distribution: CA, NC, NJ and WV,
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 = DFT and Original Applicant = RANDOX LABORATORIES, LTD.
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