Events

Safety Alert for CMV IgM

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

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
    IRD-030215
  • Event Number
    2014RD-0001256R1
  • Date
    2015-02-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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
    Fake non-reactive cmv igm tests in cmv consecutive infections not detected when the reagent cmvigm of the aforementioned reference is used with the universal diluentreference 3183971122 of the lots 17838602 and 18020901.

Device

CMV IgM
  • Model / Serial
    Reference 4784618190 Lot 179689
  • Product Description
    Immunological test in vitro for the qualitative determination of immunoglobulins M against Cytomegalovirus in serum and human plasma
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

ROCHE DIAGNOSTICS GMBH