Events

Safety Alert for Abbott VP2000 Processor Technical Name: In Vitro Diagnostic Specimen Preparation Equipment ANVISA Registration Number: 80146509035 Hazard Class: I Affected Model: Not Applicable Series Affected: 36001

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

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
    2294
  • Date
    2017-05-22
  • 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
    An Abbott Molecular representative will contact you to schedule a visit to replace the Heating Module Control Board of your VP2000 instrument. If you receive an error message indicating a communication failure between the Heating Module Control Board and the VP2000 computer or have a problem with your VP2000 instrument, contact your local Abbott Molecular Technical Support representative. If no fault occurs, you can continue to operate the instrument under normal operating conditions. Review this statement with your lab manager and staff and keep a copy for future reference. If you have any questions regarding this announcement, please contact Abbott Molecular. We apologize for any inconvenience caused. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Abbott molecular has identified a potential for premature failure of the vp2000 heating module due to incorrect voltage rating on an oscillator within the heating module control board. the oscillator is an electrical component used to communicate between the heating module and the vp2000 computer.
  • Action
    Field Action Code FA-AM-APR2017-219 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

Abbott VP2000 Processor Technical Name: In Vitro Diagnostic Specimen Preparation Equipment ANVISA...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Molecular Inc.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA