Events

Safety Alert for total BHCG II Reagent Pack / Total BHCG II calibrator

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-010316
  • Event Number
    INVIMA 2007 RD - 0000528
  • Date
    2016-03-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • 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
    Results positively slanted. vitros® systems generated results within the measurement range for samples in which it was known that they did not contain measurable hcg. the samples that were expected to be smaller than the measurement range (<2.39 miu / ml (iu / l)), could have been potentially reported. as high as 7.72 miu / ml (iu / l).

Device

total BHCG II Reagent Pack / Total BHCG II calibrator

Manufacturer

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