Events

Safety Alert for COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing of samples - preanalytical phase ANVISA registration number: 10287411162 Hazard class: I Serial numbers affected: 64002616; 64002716; 64002816; 64002916; 64003016; 64003116; 64007017 (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
    2312
  • Date
    2017-06-12
  • 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
    Verify that the Rotate Status Detection feature is used in accordance with the updated Operator's Manual. (update described in the field action notification letter).
  • Reason
    Roche diagnostics gmbh, manufacturer of the product, initiated this field action as it identified opportunities for improvements in the detection of rotation and re-labeling of the cobas p 512 pre-analytical system upon receipt of complaints from two customers reporting that non-standard samples - centrifuges were incorrectly identified as "centrifuged" by detecting the rotation state in the cobas p 512 (64x) preanalytic system. in investigating such complaints, roche diagnostica has identified that all documentation related to the state of rotation detection needs to be updated to reflect the correct use intended.
  • Action
    Field Action Code SBN-CPS-2017-010 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing o...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH