Events

Safety Alert for ELIA CCP POSITIVE CONTROL 100

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by PHADIA AB || Importer: ROPSOHN THERAPEUTICS LTDA.

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-020516
  • Event Number
    INVIMA 2009RD-0001550
  • Date
    2016-05-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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 affected lots in association with the reagentselia conjugate of references 83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01, can yield high results of the anti-ccp signals. this positive bias implies the modification of the interpretation of the results, which ranges from adverse adudate and from doubtful / negative to weakly positive. according to studies carried out by the parent company in samples of patients with rheumatoid arthritis, healthy donors and controls of different pathologies, the reported variations are consistent with the current clinical situation, and therefore, the clinical impact of this bias is not significant.

Device

ELIA CCP POSITIVE CONTROL 100

Manufacturer

PHADIA AB || Importer: ROPSOHN THERAPEUTICS LTDA