Class 3 Device Recall TOSOH

• Date Initiated by Firm: September 23, 2004
• Date Posted: November 16, 2004
• Recall Status: Terminated on December 10, 2004
• Recall Number: Z-0197-05
• Recall Event ID: 30182
• Product Classification: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
• Product: Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN
• Code Information: Lot #: DX10789, Expiration Date 10/31/2004
• Recalling Firm/ Manufacturer: Tosoh Bioscience, Inc.; 347 Oyster Point Blvd Ste 201; South San Francisco CA 94080-1913
• For Additional Information Contact: Lois Nakayama; 800-248-6764
• Manufacturer Reason for Recall: On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
• FDA Determined Cause: Other
• Action: On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.
• Quantity in Commerce: 133 boxes
• Distribution: The firm distributed product to 10 consumers and 1 distributor, to locations in CA, CO, FL, MD, NY, OH, SC and TX. No federal government agency sales/distribution centers or foreign countries received the product. The last product distributed was on 6/15/2004.
• 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.