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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Cardiac Control Level 2 and Level 3

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 Class 2 Device Recall Liquid Cardiac Control Level 2 and Level 3see related information
Date Initiated by FirmSeptember 16, 2016
Create DateDecember 14, 2016
Recall Status1 Terminated 3 on April 11, 2018
Recall NumberZ-0762-2017
Recall Event ID 75262
510(K)NumberK110534 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductThe Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
Code Information CQ5053 CQ5052
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories
55 The Diamond Road
Antrim United Kingdom
For Additional Information Contact
304-728-2890
Manufacturer Reason
for Recall		An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionRandox sent an Urgent Field Safety Notice dated September 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please note the control value sheets have been updated with the new values. A FSN has been completed to advise customers on the appropriate action to take. For further questions, please call (304) 728-2890.
Quantity in Commerce2817
DistributionWorldwide Distribution - US Distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JJY
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