Class 3 Device Recall DiaSorin AntiCardiolipin IgA ELISA Kit,

• Date Initiated by Firm: November 01, 2004
• Date Posted: June 25, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0927-05
• Recall Event ID: 30950
• 510(K)Number: K001981
• Product Classification: System, Test, Anticardiolipin Immunological - Product Code MID
• Product: DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
• Code Information: Catalog no. 7800, lots FS1123 and FS2184
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: DiaSorin Technical Service; 800-328-1482
• Manufacturer Reason for Recall: DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
• FDA Determined Cause: Other
• Action: Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.
• Quantity in Commerce: 49
• Distribution: NY, KS, GA & MT
• 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