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U.S. Department of Health and Human Services

Class 3 Device Recall Liquid Urine Control Level 3

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  Class 3 Device Recall Liquid Urine Control Level 3 see related information
Date Initiated by Firm April 27, 2017
Date Posted May 26, 2017
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-2167-2017
Recall Event ID 77152
510(K)Number K110904  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Urine Control Level 3

For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Code Information Catalogue number UC5075 Batch number 907UC
Recalling Firm/
Manufacturer		 Randox Laboratories
515 Industrial Blvd
Kearneysville WV 25430-2778
Manufacturer Reason
for Recall		 According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
FDA Determined
Cause 2		 Error in labeling
Action Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.
Quantity in Commerce 198 kits
Distribution Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
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, LTD.
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