Class 3 Device Recall DiaSorin ETIEAG assay kit

• Date Initiated by Firm: November 01, 2004
• Date Posted: March 29, 2005
• Recall Status: Terminated 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: 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