Events

Safety Alert for ADVIA 560 and 360 HEMATOLOGY SYSTEM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Diatron Mi Plc || Siemens Healthcare Diagnostics Inc.

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
    I1704-128
  • Event Number
    2015DM-0013266
  • Date
    2017-04-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=94
  • 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 obtain multiple discordant records for the same sample id, which may result in a misinterpretation of the complete data, blood count values, appropriate follow-up and / or delay in testing, leading to their being presented adverse events on patients.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • Model / Serial
  • Product Description
    The ADVIA 560 AND 360 HEMATOLOGY SYSTEM is a fully automated, high quality hematology system for use in in vitro diagnostics in clinical laboratories. The system uses the impedance method for the measurement of leukocyte (WBC), erythrocyte (RBC) and platelet (PLT) concentrations. The hemoglobin concentration (HGB) of red blood cells is measured by photometric refraction. The system provides a differential measurement of the leukocyte formula of 5 parts of WBC (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow decitometer technology. The ADVIA 560 and the ADVIA360 HEMATOLOGY SYSTEM identify patients with hematological parameters inside and outside the established reference ranges. The system can process up to 100 μl of blood completely anticoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

Diatron Mi Plc || Siemens Healthcare Diagnostics Inc
  • Source
    NIDFSINVIMA