Class 2 Device Recall DiaSorin AntiCardiolipin IgA ELISA kit

• Date Initiated by Firm: January 23, 2004
• Date Posted: March 18, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0632-05
• Recall Event ID: 30919
• 510(K)Number: K001981
• Product Classification: System, Test, Anticardiolipin Immunological - Product Code MID
• Product: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
• Code Information: catalog # 7800, lot # 039229, expiration date 12/23/04
• FEI Number: 2182595
• 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: DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
• FDA Determined Cause: Other
• Action: Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
• Quantity in Commerce: 16 kits
• Distribution: GA, NY & KS
• 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 = MID