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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Cardiac Control

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  Class 2 Device Recall Liquid Cardiac Control see related information
Date Initiated by Firm October 02, 2018
Create Date November 03, 2018
Recall Status1 Terminated 3 on May 30, 2019
Recall Number Z-0381-2019
Recall Event ID 81159
510(K)Number K110534  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Cardiac Control, CQ5052
Code Information All lots
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
FDA Determined
Cause 2		 Under Investigation by firm
Action On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials. Customers were advised to take the following actions: - Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays. - Discuss the contents of this notice with your Medical Director. - Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays. - Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. - Contact your local Randox sales representative for alternative product details. You may contact the firm at technical.services@randox.com.
Quantity in Commerce 1738
Distribution Distributed to IN, NY, PR, 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 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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