Class 2 Device Recall

• Date Initiated by Firm: August 31, 2005
• Date Posted: October 06, 2005
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-0007-06
• Recall Event ID: 33412
• 510(K)Number: K042676
• Product Classification: System, Test, Human Chorionic Gonadotropin - Product Code DHA
• Product: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
• Code Information: Lot #62-500262
• FEI Number: 2050095
• Recalling Firm/ Manufacturer: Nichols Institute Diagnostics; 1311 Calle Batido; San Clemente CA 92673-6316
• For Additional Information Contact: John Chiechi; 949-940-7377
• Manufacturer Reason for Recall: Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
• FDA Determined Cause: Other
• Action: Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.
• Quantity in Commerce: 174
• Distribution: Nationwide and China, Germany, & Australia
• 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 = DHA