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U.S. Department of Health and Human Services

Class 3 Device Recall ETIEBNAG

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  Class 3 Device Recall ETIEBNAG see related information
Date Initiated by Firm March 14, 2007
Date Posted April 24, 2007
Recall Status1 Terminated 3 on July 15, 2007
Recall Number Z-0755-2007
Recall Event ID 37691
510(K)Number K946158  
Product Classification In vitro diagnostic - Product Code LLM
Product DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic.
For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285
Code Information 3160240B/1
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
Manufacturer Reason
for Recall		 A lot to lot inconsistency was noted on kits of ETI EBNA G.
FDA Determined
Cause 2		 Other
Action All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product.
Quantity in Commerce 203
Distribution Nationwide and Canada.
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 = LLM and Original Applicant = INCSTAR CORP.
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