Events

Safety Alert for unkown device

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ORTHO CLINICAL DIAGNOSTICS || Importer: 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
    RRD-030716
  • Event Number
    INVIMA 2014RD-000011-R2
  • Date
    2016-07-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=133
  • 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
    Failure to increase the results signal / cut-off (s / c) of the negative control vitros hbsag, the results generated by the negative controls of the affected lots showed a positive deviation when they were close to the expiry date (5 days after the reconstitution), this inconvenient can also be presented with the positive control; however, the results of patient samples are not affected. the first results of the investigations have revealed that the anomaly was related to a specific batch of raw material used to manufacture the affected lots.

Device

unkown device

Manufacturer

ORTHO CLINICAL DIAGNOSTICS || Importer: JOHNSON & JOHNSON DE COLOMBIA S.A