Events

Recall of Device Recall Tosoh Bioscience HLC723G8 , Analyzer

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
    75727
  • Event Risk Class
    Class 2
  • Event Number
    Z-1225-2017
  • Event Initiated Date
    2016-11-07
  • 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=151106
  • 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
    Control, hemoglobin, abnormal - Product Code JCM
  • Reason
    The device defect associated with this recall may result in hba1c values with a negative bias in patients with the hemoglobin variants c, d, e and s. the negative bias occurs at the higher levels of hba1c, e.G. 9%, but not at the diagnostic medical decision point of 6.5%.
  • Action
    Recall notification letters were distributed to customers on 11/7/16. The letters instructed customers to review the chormatography to determine whether or not a variant peak was detected. If so, restest the sample using an alternative method.

Device

Device Recall Tosoh Bioscience HLC723G8 , Analyzer
  • Model / Serial
    All active analyzers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,
  • Product Description
    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
  • 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