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
    I1604-176
  • Event Number
    2015DM-0013266
  • Date
    2016-04-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 has identified that after its use erroneous results can be obtained, since they do not indicate the following flag: the warning flag for low sample volumes (w) and the flags of morphology that indicate the presence of immature granulocytes (g) and atypical lymphocytes (g) , which could lead to potentially adverse events on patients due to diagnostic errors.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • Model / Serial
    ADVIA 560, serial S020202, S020201, S020200 and S020197, with software version 4.1.2133
  • Product Description
    The ADVIA 560 and 360 HEMATOLOGY SYSTEM are 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 deleucocyte concentrations (WBC), erythrocytes (RBC) and platelets (PLT). The concentration of hemoglobin (HGB) of the red blood cells semide by photometric refraction. The system provides a differential measurement of the WBC 5-part leukocyte formula (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow cytometry technology. The ADVIA 560 and the ADVIA 360 HEMATOLOGY SYSTEM identify patients with hematological parameters within and outside the established reference ranges. The system can process up to 100 ul of whole blood that is agicoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

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