Events

Safety Alert for Laboratory Information Systems with Microbiology Modules: (1) Version 5.23, (2) Version 5.3

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Sunquest Information Systems 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
    344
  • Date
    2001-11-23
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    A defect reported in the above information systems may cause lab test results to be printed incorrectly. the manufacturer initiated the correction by product safety note numbers psn-01-l08 and cn-01-07 dated march 23 and april 16, 2001 respectively.
  • Action
    Please verify receipt of Product Safety Note numbers PSN-01-L08 and CN-01-07 dated March 23 and April 16, 2001, respectively, submitted by Sunquest Information Systems. If the product is being used, follow the temporary procedures set out in the above-described Product Safety Note number CN-01-07, submitted by Sunquest Information Systems. Product repair can be obtained by contacting Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact your local representative or Sunquest Information Systems at 1 (520) 382-6170 in the United States. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Laboratory Information Systems with Microbiology Modules: (1) Version 5.23, (2) Version 5.3

Manufacturer

Sunquest Information Systems Inc
  • Source
    ANVSANVISA