Events

Safety Alert for Preanalytical Equipment for Sample Management - ROCHE

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
    I1603-86
  • Event Number
    2015DM-0013314
  • Date
    2016-02-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 he was notified of a case in which the uncovered sample tubes are not placed correctly back in the rack tube transport (rtt), the open sample tubes were found in the decapper outsorter area, contaminating the equipment with blood , the material of the tubes was spilled and could not be used to carry out the analyzes, leading to potentially adverse events on the patients and reprocesses for the analysis of the samples.

Device

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

Manufacturer

Roche Diagnostics GMBH