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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin ETIEAG assay kit

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  Class 3 Device Recall DiaSorin ETIEAG assay kit see related information
Date Initiated by Firm November 01, 2004
Date Posted March 29, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0658-05
Recall Event ID 30953
510(K)Number K992191  
Product Classification Epstein-Barr Virus, Other - Product Code LSE
Product DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
Code Information catalog no. 7570, Lot # 113963C
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Services
800-328-1482
Manufacturer Reason
for Recall		 The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.
FDA Determined
Cause 2		 Other
Action Customers were notified of the product and problem via telephone and instructed to check any remaining inventory and discard all incorrect plates. Replacement plates were offered.
Quantity in Commerce 46
Distribution FL, TX & UT
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 = LSE and Original Applicant = DIASORIN, INC.
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