Z-0197-05

Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays...

Name: Z-0197-05 Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays...
Creator: Tosoh Bioscience, Inc.
Published: 2004-09-23
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2004-09-23 / Terminated

FDA source

Tosoh Bioscience, Inc. began a recall of 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... on 2004-09-23. The reason FDA records is "On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0197-05
Status: Terminated
Initiated: 2004-09-23
Posted: 2004-11-16
Terminated: 2004-12-10
Recalling firm: Tosoh Bioscience Inc
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
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Reason for recall: On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
FDA root 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.
Product codes and lots: Lot #: DX10789, Expiration Date 10/31/2004

Product code NIG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)