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U.S. Department of Health and Human Services

Class 1 Device Recall Tosoh

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 Class 1 Device Recall Tosohsee related information
Date Initiated by FirmApril 02, 2003
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on June 15, 2005
Recall NumberZ-0218-05
Recall Event ID 30183
510(K)NumberK971103 
Product Classification System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
ProductTOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
Code Information All units of these models.
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
347 Oyster Point Blvd Ste 201
South San Francisco CA 94080-1913
For Additional Information ContactLois Nakayama
650-615-4970
Manufacturer Reason
for Recall		A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.
FDA Determined
Cause 2		Other
ActionThe firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.
Quantity in Commerce81 units
Distribution81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NIG
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