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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Cardiac Control Level 3

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  Class 2 Device Recall Liquid Cardiac Control Level 3 see related information
Date Initiated by Firm June 08, 2018
Create Date July 30, 2018
Recall Status1 Terminated 3 on November 05, 2018
Recall Number Z-2575-2018
Recall Event ID 80475
510(K)Number K110534  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Cardiac Control - Level 3, cat. no. CQ5053

Product Usage:
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
Code Information Lot 4245CK.
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 8, 2018, the firm issued an Urgent Medical Device Recall letter to affected consignees. The letter stated that Randox has confirmed Liquid Cardiac Control CQ5053 Lot: 4245CK is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. Customers were instructed to do the following: " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Update kits with corrected IFU's excluding Troponin T values. " Complete and return the vigilance response section of this form to technical.services@randox.com within five working days.) In addition, distributors were instructed to send a copy of the letter to all affected customers and to those who need to be aware within their organization.
Quantity in Commerce 1 kit (US), 602 kits (OUS)
Distribution Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = RANDOX LABORATORIES LIMITED
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