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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Cardiac Quality Control Level 3

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  Class 2 Device Recall Liquid Cardiac Quality Control Level 3 see related information
Date Initiated by Firm August 08, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on September 05, 2018
Recall Number Z-0937-2018
Recall Event ID 79035
510(K)Number K110534  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Cardiac Control CQ5053
Code Information Lot 4069CK
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore 55 The Diamond Road
Crumlin United Kingdom
Manufacturer Reason
for Recall		 Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.
Quantity in Commerce 450 kits
Distribution Nationally
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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