Events

Safety Alert for 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 || Sysmex Corporation Kakogawa Factory.

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
    I1702-60
  • Event Number
    2010DM-0005612
  • Date
    2017-02-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 confirmed that, in very rare circumstances, a false negative result for the innovance d-dimer assay may be reported by the referenced devices, as a result of an antigen overflow error that triggers an automatic re-reading of 1/19 and the unprocessed signal the reading is lower than the white limit method (lob), leading to alterations in the result.

Device

Coagulation Analyzer
  • Model / Serial
  • Product Description
    The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative decoagulation tests by coagulometry, immunological and chromogenic. Continuous random access. Uses plasma samples for in-vitro diagnostic tests (IVD) of PT, APTT, TT, fibrinogen, D-Dimero, AT-III; PLG; PC and individual factors I to XIII. It is in an automated system that reports the values of the tests and communicates the results of the patient's clinicians. The reagents that are used with the SYMEX CS2000I / CS2100I equipment have their respective health records.
  • Manufacturer
    Sysmex Corporation || Sysmex Corporation Kakogawa Factory

Manufacturer

Sysmex Corporation || Sysmex Corporation Kakogawa Factory