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Terminated

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

FDA Recall Z-0197-05 · Posted 2004-11-16

Recalling FirmTosoh Bioscience, Inc.
Recall StatusTerminated
Product CodeNIG
Date Initiated2004-09-23
Date Terminated2004-12-10
Product Quantity133 boxes

Reason for Recall

On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.

Firm Action

On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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