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U.S. Department of Health and Human Services

Class 3 Device Recall TOSOH

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  Class 3 Device Recall TOSOH see related information
Date Initiated by Firm September 23, 2004
Date Posted November 16, 2004
Recall Status1 Terminated 3 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/
Tosoh Bioscience, Inc.
347 Oyster Point Blvd Ste 201
South San Francisco CA 94080-1913
For Additional Information Contact Lois Nakayama
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 2
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.