Events

Recall of G8 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TOSOH CORPORATION.

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
    106500
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    In the study "effects of hemoglobin c d e and s traits on measurements of hemoglobin a1c by twelve methods" published in clinica chimica acta the tosoh automated glycohemoglobin analyzer hlc-723g8 variant analysis mode showed significant interference with hba1c results with one or more variants at 9% hba1c. clinically significant interference was defined as >7% difference from hbaa at 6 or 9% hba1c (+-0.42% or +-0.63% hba1c respectively). the paper further explains that the tosoh methods are ion-exchange hplc where inspection of the chromatogram reveals the presence of the variant.

Device

G8 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 021560 (Lot serial: N/A)
  • Product Description
    G8 Automated Glycohemoglobin System-Instrument
  • Manufacturer
    TOSOH CORPORATION

Manufacturer

TOSOH CORPORATION
  • Manufacturer Address
    TOKYO
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    HC