Events

Safety Alert for CASSETTES OF THE ORTHO BIOVUE SYSTEM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ortho Clínica 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
    I-RD-03-07-13
  • Date
    2013-07-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=216
  • 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 use of the cassette of multiple affected reagents may lead to false positive or false negative results causing an erroneous classification of the patient's blood group or donors or incorrect results of antibody detection.

Device

CASSETTES OF THE ORTHO BIOVUE SYSTEM
  • Model / Serial
  • Product Description
    Reagents used to determine the Blood Group Anti D in samples of human origin. Reagents used for recognition of antigens related to human red blood cells.
  • Manufacturer
    Ortho Clínica Diagnostics, INC

Manufacturer

Ortho Clínica Diagnostics, INC