Z-0218-05

TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400...

Name: Z-0218-05 TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400...
Creator: Tosoh Bioscience, Inc.
Published: 2003-04-02
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2003-04-02 / Terminated / root cause: software

FDA source

Tosoh Bioscience, Inc. began a recall of TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media on 2003-04-02. The reason FDA records is "A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0218-05
Status: Terminated
Initiated: 2003-04-02
Posted: 2004-11-30
Terminated: 2005-06-15
Recalling firm: Tosoh Bioscience Inc
Product: TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
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.
Root cause tag: software
FDA root cause: Other
Action: The 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 commerce: 81 units
Distribution: 81 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.
Product codes and lots: All units of these models.

Product code NIG

K971103Class IAia Nexia-Automated Enzyme Immunoassay SystemTosoh Medics, Inc. / cleared 1997-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)