Events

Recall of Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode

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
    56584
  • Event Risk Class
    Class 3
  • Event Number
    Z-1075-2013
  • Event Initiated Date
    2010-08-18
  • Event Date Posted
    2013-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94017
  • 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
    Hemoglobin a2 quantitation - Product Code JPD
  • Reason
    The beta-thalessemia mode of the g7 analyzer-beta thalassemia mode is an automated high performance liquid chromatography (hplc) system that separates and reports hbf and hba2 quantitative percentages in whole blood. the firm received complaints that the a2 peak could not be detected with the g7 beta-thalessemia columns.
  • Action
    Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.

Device

Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode
  • Model / Serial
    11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
  • Product Description
    G7 HPLC. || Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Manufacturer Address
    Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
  • Source
    USFDA