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
    33199
  • Event Risk Class
    Class 3
  • Event Number
    Z-0131-06
  • Event Initiated Date
    2005-08-18
  • Event Date Posted
    2005-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41476
  • 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
    Mixture, Hematology Quality Control - Product Code JPK
  • Reason
    The firm has received reports that vials of the level ii were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
  • Action
    On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.

Device

Tosoh
  • Model / Serial
    Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
  • Product Description
    Tosoh brand Glycohemoglobin A1c Controls I & II, || Catalog Number: 992133; || Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
  • 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