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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Rx Series Copper Assay

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 Class 2 Device Recall Randox Rx Series Copper Assaysee related information
Date Initiated by FirmNovember 29, 2023
Date PostedFebruary 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0992-2024
Recall Event ID 93775
Product Classification Diethyldithiocarbamate (colorimetric), copper - Product Code JKZ
ProductRX Series Copper (Cu) Assay Ref. Number CU2340
Code Information Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
FDA Determined
Cause 2		Component design/selection
ActionRANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US 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 organization.
Quantity in Commerce3,053 kits (2 US, 3,051 OUS)
DistributionUS Nationwide distribution in the states of SC and OK.
Total Product Life CycleTPLC 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.
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