Events

Safety Alert for Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class I, Serial Number: 7501721; 7501821; 7501921; 7502021.

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
    1706
  • Date
    2015-10-01
  • 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
    Unexpected spills, aerosols, or blood droplets may occur when equipment is improperly unplugged. There are no known cases of serious adverse events. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Inadvertent opening of the sample tube during the transport process with risk of user contamination and sample loss. the root cause of the problem is related to the design of the repellent plate bevel, which is the component of the tube inlet basin.
  • Action
    The company will make a field correction of the equipment in which it will develop a kit of modification for the equipment. Until the corrective measure with the modification kit is implemented, if the problem occurs, the equipment must be cleaned according to the operating manual.

Device

Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH