Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test c
FDA device recall Z-0197-05 · posted 2004-11-16 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- Reason for recall
- On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
- Action taken
- On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIG
- Quantity affected
- 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
- Date initiated
- 2004-09-23
- Date posted
- 2004-11-16
- Date terminated
- 2004-12-10
- Location
- South San Francisco, CA
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