Events

Safety Alert for TOSOH G7 HPLC automated system analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Tosoh AIA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1703-94
  • Event Number
    2009DM-0004739
  • Date
    2017-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that the referenced medical devices can give hba1c values with a negative bias for patients with variants of hemoglobin c, d, e and s with higher levels of hba1c (for example, 9%), but not at the level of medical diagnosis. 6.5%, which could lead to delays in the processing of samples.

Device

TOSOH G7 HPLC automated system analyzer
  • Model / Serial
  • Product Description
    The TOSOH G7 HPLC automated system analyzer is a fully automated high-performance liquid chromatography instrument that rapidly and precisely separates hemoglobins found naturally in the blood. Glycosylated hemoglobins and other components of hemoglobin are extracted depending on the charge of the molecule in relation to an incremental gradient that pass through a non-porous cationic column. In the mode of HbA1c variant analysis, the predetermined windows are configured in the software to detect the presence of HbA1a, HbA1b, HbF, labile HbA1c (la1c), HbA1c (sa1c), and a0. The reagents that are used with the TOSOH G7 analyzers have a respective health record.
  • Manufacturer
    Tosoh AIA

Manufacturer

Tosoh AIA
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    NIDFSINVIMA