Events

Recall of TOSOH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tosoh Bioscience, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30182
  • Event Risk Class
    Class 3
  • Event Number
    Z-0197-05
  • Event Initiated Date
    2004-09-23
  • Event Date Posted
    2004-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35320
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
  • Reason
    On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.
  • Action
    On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.

Device

TOSOH
  • Model / Serial
    Lot #: DX10789, Expiration Date 10/31/2004
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
    Tosoh Bioscience, Inc.

Manufacturer

Tosoh Bioscience, Inc.
  • Manufacturer Address
    Tosoh Bioscience, Inc., 347 Oyster Point Blvd Ste 201, South San Francisco CA 94080-1913
  • Source
    USFDA