Events

Safety Alert for LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

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

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
    710
  • Date
    2002-07-25
  • 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
    Abbott Laboratories of Brazil Ltda., Is working to accelerate the replacement of the LCx Neisseria Gonorrhoeae product. Lot: 84075M400. and recommends alternative methods for performing the test.///////NOTE: Clinical studies described in the Technical Manual of the trial, represent a small percentage of patient samples that are close to the test cutoff (<0.80). Based on this data, review of patient outcomes is not recommended because the risk of a low positive test being reported as negative is minimal. Thus with any diagnostic test, the results of the LCx Neisseria Gonorrhoeae kit. Batch: 84075M400 should be interpreted in conjunction with other clinical and laboratory data.
  • Reason
    Studies conducted by abbott laboratories have demonstrated that the analytical sensitivity may be out of the one specified in the package insert as being 10 colony forming units. these studies were based on a panel with sensitivity close to the assay cutoff (<0.80) and may generate a positive-low as negative.
  • Action
    Discontinue use of the LCx Neisseria Gonorrhoeae kit. Lot: 84075M400

Device

LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

Manufacturer

Abbott Laboratórios do Brasil Ltda.
  • Source
    ANVSANVISA