Tosoh Bioscience, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Tosoh Bioscience, Inc.
Lot Codes / Batch Numbers
Lot #: DX10789, Expiration Date 10/31/2004
Products Sold
Lot #: DX10789, Expiration Date 10/31/2004
Tosoh Bioscience, Inc. is recalling Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 1 due to On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
Recommended Action
Per FDA guidance
On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, MD, NY, OH, OR, SC, TX
Page updated: Jan 10, 2026