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U.S. Department of Health and Human Services

Class 2 Device Recall IgE Calibrator Series

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  Class 2 Device Recall IgE Calibrator Series see related information
Date Initiated by Firm September 07, 2016
Date Posted October 06, 2016
Recall Status1 Terminated 3 on September 07, 2017
Recall Number Z-0050-2017
Recall Event ID 75208
510(K)Number K010855  
Product Classification Ige, antigen, antiserum, control - Product Code DGC
Product IgE Calibrator Series
Code Information Catalogue number  IE2492  Batch number  354213, 386994
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm plans on contacting each consignee about the recall.
Quantity in Commerce 4
Distribution All consignees are in the US.
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 = DGC and Original Applicant = RANDOX LABORATORIES, LTD.
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