Events

Safety Alert for Immunoassay Analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Healthcare Diagnostics Productos Ltd. || 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
    I1506-256
  • Event Number
    2008DM-0002621
  • Date
    2015-06-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=177
  • 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 affirms that the cup holders and inserts demicromuestra referenced may not meet the specifications for detection of sample level, producing error messages or failure to execute the test, leading to possible occurrences of adverse events on patients or difficulties in the diagnosis.

Device

Immunoassay Analyzer
  • Model / Serial
    1000, 2000 and 2000Xpi concerning the cup holders and micromesh inserts part number 10385360, || 10385319 and 10385209.
  • Product Description
    This equipment is an automated analyzer for continuous random access chemiluminescence immunoassay tests. Use urine, serum or plasma samples for in-vitro diagnostic tests (IVD). It reports values of the tests and communicates the clinical results of the patient.
  • Manufacturer
    Siemens Healthcare Diagnostics Productos Ltd. || Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Productos Ltd. || Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA