Events

Recall of Device Recall AIAPACK TgAb CONTROL SET

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
    76659
  • Event Risk Class
    Class 3
  • Event Number
    Z-2169-2017
  • Event Initiated Date
    2017-02-08
  • Event Date Posted
    2017-05-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154073
  • 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, thyroid autoantibody - Product Code JZO
  • Reason
    The label contains two different methodologies. quality control values for non-fda approved methodology (cl) are on the label in addition to the fda approved methodology values (aia). two sets of instructions were included on the label.
  • Action
    On 3/3/2017 the firm sent recall notificaion letters to their customers.

Device

Device Recall AIAPACK TgAb CONTROL SET
  • Model / Serial
    TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
  • Product Description
    AIA-PACK TgAb CONTROL SET
  • Manufacturer
    Tosoh Bioscience, Inc.

Manufacturer

Tosoh Bioscience, Inc.
  • Manufacturer Address
    Tosoh Bioscience, Inc., 6000 Shoreline Ct Ste 101, South San Francisco CA 94080-7606
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    USFDA