Events

Safety Alert for Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products under registration 10287411162 (cobas p512 and p612) Technical name: SAMPLE PROCESSOR ACCESSORY FOR HEALTH DIAGNOSIS ANVISA registration number: 10287411162 Hazard class: I Numbers Affected series: 20496176 204C5683 204C5684 204C5691 204C5692 204C5693 204C5694 204C5695 204C5700 (Roche stock) 204C5701 (Roche stock) 204C5702 (Roche stock)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda; 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
    2291
  • Date
    2017-05-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    If you identify that your unit is affected by rack vibration and samples are required for further processing, the unit should not be used until the Roche Diagnostica Brazil Field Service Representative performs the adjustment procedure. Potentially affected sample tubes should be disposed of in accordance with local regulations. An adjustment procedure that solves this problem is now available. All affected systems will be adjusted by a Field Service Representative from Roche Diagnostics Brazil.
  • Reason
    Roche diagnostics gmbh, a legal offshore manufacturer, has received a 5-position rack-related complaint on the output unit unit that was not being gently pushed into the tray and may cause rack vibration during sample transport, leading to possible spillage of the sample tube material.
  • Action
    Field Action Code SBN-CPS-2017-008 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products und...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH