Events

Safety Alert for Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO DIAGNOSIS Anvisa Registration Number: 80146501830 Hazard Class: I Affected Model: Not applicable Affected serial numbers: ACP009

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Inpeco S.A..

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
    2171
  • Date
    2016-12-13
  • 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
    Customer Service or its representatives will visit the customer's location to replace the cables. Abbott will replace potentially non-compliant cables in the coming months. As parts are available, your Abbott service team will contact you to schedule replacement cables. Keep a copy of this statement in your lab files.
  • Reason
    Abbott diagnostics received the enclosed letter from inpeco, manufacturer of the accelerator a3600. you are receiving this notice because the products listed below may have been installed with a potentially non-compliant cable that could overheat. impacted specific cables connect the power distribution bus to the following modules: storage and retrieval module (srm) 9000; storage and retrieval module (srm) 15000; centrifuge module and i2000sr interface module.
  • Action
    Field Action Code FA27OCT2016 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA