Safety Alert for Access Ostase calibrators

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BECKMAN COULTER || Importer: ROCHEM BIOCARE 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
  • Event Number
    INVIMA 2008RD-0001032
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Ostase access gauges and qcaccess ostase quality control are not stable as foreseen on the expiry date stated on the product label.


  • Model / Serial
    Access Gauges: Ref. 37305 and Lots: 528936 and 528938 || Access Ostase QC: Ref. 37309 and Lots: 528937 and 528939
  • Product Description
    Calibration, control and determination of the related analytes in samples from the human organism.
  • Manufacturer