Events

Recall of Device Recall G7 Variant Elution Buffer HiS No. 1 (M)

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
    71493
  • Event Risk Class
    Class 3
  • Event Number
    Z-2066-2015
  • Event Initiated Date
    2015-02-10
  • Event Date Posted
    2015-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137951
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Reason
    The g7 variant elution buffer his no. 1 (m) is incorrectly labeled with an expiration date of october 2015. the correct expiration date is october 2014.
  • Action
    Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.

Device

Device Recall G7 Variant Elution Buffer HiS No. 1 (M)
  • Model / Serial
    Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Us Nationwide Distribution in the state ID including PR.
  • Product Description
    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. || Product Usage: || G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
  • 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