Events

Safety Alert for Coagulation Analyzer for PT and INR

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Product Gmbh || Universal Biosensor Pty Ltd.

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
    I1609-379
  • Event Number
    2015DM-0013131
  • Date
    2016-09-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 it has detected a defect in the software in the referenced system due to failures in the calibration of the testpak and the status of the quality control (qc), which could lead to potential delays in the processing of the samples.

Device

Coagulation Analyzer for PT and INR
  • Model / Serial
    Stratus CS 200, all serials.
  • Product Description
    The coagulation analyzer for PT and INR XPRECIA STRIDE is designed to be used by professional healthcare personnel and / or appropriately trained patients, to perform the quantitative determination of the time of the thromboembolism (PT) and the standardized INR index for the control of oral anticoagulant therapy conwarfarin , antagonist of vitamin k, within the intrinsic system of coagulation. The system uses the total capillary blood freshly extracted (by digital puncture) from the patient and is measured through the test strips designed for PT and INR.
  • Manufacturer
    Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Product Gmbh || Universal Biosensor Pty Ltd

Manufacturer

Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagn...
  • Source
    NIDFSINVIMA