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
This recall has been terminated (originally issued November 16, 2004).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- September 23, 2004
- Posted
- November 16, 2004
- Terminated
- December 10, 2004
- Recall Number
- Z-0197-05
- Quantity
- 133 boxes
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
Reason for Recall
On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
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 / Code Info
Lot #: DX10789, Expiration Date 10/31/2004
Root Cause
Other
Action Taken
On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.
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