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
    30183
  • Event Risk Class
    Class 1
  • Event Number
    Z-0218-05
  • Event Initiated Date
    2003-04-02
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35321
  • 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
    A software upgrade was released by the firm for its aia-600 ii analyzers, in that washing deficiencies caused by the analyzer were corrected.
  • Action
    The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.

Device

Tosoh
  • Model / Serial
    All units of these models.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.
  • Product Description
    TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media
  • 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