Events

Safety Alert for Affirmagen ®4, Ortho ® Coombs Control, Selectogen ®, 0,8% Surgiscreen ®, 0,8% Resolve ® Panel C.

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ORTHO CLINICAL DIAGNOSTIC. || Imported by: JOHNSON & JOHNSON DE || COLOMBIA S.A..

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-021116
  • Event Number
    INVIMA 2014RD-0002936 INVIMA 2014RD-0002865 ; INVIMA 2014RD-0002857 INVIMA 2014RD-0002852 ; INVIMA 2014RD-0002858.
  • Date
    2016-11-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • 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

Device

Affirmagen ®4, Ortho ® Coombs Control, Selectogen ®, 0,8% Surgiscreen ®, 0,8% Resolve ® Panel C.
  • Model / Serial
  • Product Description
    Affirmagen®4: To confirm the determination of the ABO Hematic group. Ortho® Coombs Control: qualitative test to confirm the validity of the Selectogen® negative antiglobulin tests: Qualitative test for detection of unexpected antibodies. 0.8% Surgiscreen®:, 08,% and Resolve® Panel C: For use with the Ortho Biovue system to detect or identify irregular Blood Group Bodies
  • Manufacturer
    ORTHO CLINICAL DIAGNOSTIC. || Imported by: JOHNSON & JOHNSON DE || COLOMBIA S.A.

Manufacturer

ORTHO CLINICAL DIAGNOSTIC. || Imported by: JOHNSON & JOHNSON DE || COLOMBIA S.A.