Events

Safety Alert for Name of product: PHT INTACTO IMMULITE 2000 Technical name: INTACT PYTHROID HORMONE (iPTH) ANVISA registration number: 10345160672 Hazard class: II Affected model: 200 test kit / 600 test kit Affected serial numbers: 320

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd.

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
    2077
  • Date
    2016-12-22
  • 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
    Siemens recommends discontinuation of use of lot 320.
  • Reason
    Siemens has confirmed that lot 320 of the intacto immulite 2000 / immulite 2000 xpi pth kit can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg / ml in serum patient or edta vs. a batch of reference kit.
  • Action
    Field Action BMI Code 16-27 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Notification to the client.

Device

Name of product: PHT INTACTO IMMULITE 2000 Technical name: INTACT PYTHROID HORMONE (iPTH) ANVISA ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA