Events

Safety Alert for automatic blood coagulation analyzer

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

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
    I1401-6
  • Event Number
    2010DM-0005612
  • Date
    2014-01-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=212
  • 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
    It was stated by the manufacturer that some faults associated with the medical device software may be present during the processing of the sample, generating erroneous outputs of the determined values, which may lead to inaccurate values being presented in the patient's test results.

Device

automatic blood coagulation analyzer
  • Model / Serial
    CS-2100I, CS-2000I
  • Product Description
    The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative coagulation, immunological and chromogenic coagulation tests. Continuous random access. Uses deplasma samples for in-vitro diagnostic (IVD) assays of PT, APTT, TT, fibrinogen, D-Dimero; AT-III; PLG; PC and individual factors I to XIII. It is an automated system that reports the values of the tests and communicates the clinical results of the patient. The reagents that are used with the SYSEX®CS2000I / CS2100I devices have respective health records.
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation