Events

Safety Alert for IMMULITE 2000 CMV IgM I

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 || Imported by: SIEMENS S.A./ VELEZ LAB..

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
    RRD-020916
  • Event Number
    INVIMA 2008RD-0000994.
  • Date
    2016-09-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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 healthcare agency notifies that siemens healthcarediagnostics has confirmed a greater inaccuracy in some.

Device

IMMULITE 2000 CMV IgM I
  • Model / Serial
    Catalog number L2KCM2 Siemens Material Number (SMN) || 10381320 Lot number: 255, 256257, 258259, 260261, || 262263, 264266, 267.
  • Product Description
    QUANTITATIVE DETECTION OF IgM ANTIBODIES FOR CYMOMEGALOVIRUS IN SERUM OR HUMANOCYMIC PLASMA HELP IN THE DIAGNOSIS OF GAD INFECTION.
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS || Imported by: SIEMENS S.A./ VELEZ LAB.

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS || Imported by: SIEMENS S.A./ VELEZ LAB.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA