Events

Safety Alert for Hemostasis Analyzer - STA COMPACT

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

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
    R1702-28
  • Event Number
    2010DM-0006216
  • Date
    2017-02-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=104
  • 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 detected reports of erroneous tpta results when using the referenced consumables, leading to delays in the analysis of samples and possible adverse events on the patient.

Device

Hemostasis Analyzer - STA COMPACT
  • Model / Serial
  • Product Description
    The STA COMPACT team is a medical device for in vitro diagnosis, consisting of a laboratory analyzer and software, designed to perform in vitro tests for the diagnosis and monitoring of pathologies related to hemostasis. The STACOMPACT is an automatic analysis instrument that allows to perform chronometry tests (measurement of coagulation time), decolorimetry or immunology (microllate method) in deplasma samples.
  • Manufacturer
    Diagnostica Stago S.A.S

Manufacturer

Diagnostica Stago S.A.S