FDA Medical Device Recalls (openFDA)
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 number
- Z-0197-05
- 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
- Status
- Terminated
- Initiated
- 2004-09-23
- Posted
- 2004-11-16
- Terminated
- 2004-12-10
- Reason
- On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
- 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
- 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.
- Lot, serial or model codes
- Lot #: DX10789, Expiration Date 10/31/2004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NIG
- Firm FEI
- 1000123732
- Firm city
- South San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28