Events

Safety Alert for Preanalytical Equipment for Sample Management

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Roche Diagnostics Gmbh.

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
    I1703-86
  • Event Number
    2015DM-0013314
  • Date
    2017-03-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=98
  • 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 manufacturer reports that when the referenced system uses disposable tips without a filter, the software can incorrectly calculate the depth of immersion, causing an aspiration of a greater number of clots, which could lead to delays in obtaining results from analysis carried out until the contamination of the samples.

Device

Preanalytical Equipment for Sample Management
  • Model / Serial
  • Product Description
    The cobas 8100 preanalytic system and the p512 and p612 models is a modular unit interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge patient samples, remove and insert the stoppers, apply barcode labels and with the pipettor prepare the aliquots from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples between the analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analysis. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics Gmbh

Manufacturer

Roche Diagnostics Gmbh