Events

Safety Alert for D-dimer IMMULITE / IMMULITE 1000 Technical Name: D-DÍMERO Registration Number ANVISA: 10345161779 Hazard Class: III Affected Model: 100 test kit Serial Affected: 346

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
    2082
  • Date
    2016-11-25
  • 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
    Siemens has isolated the cause of the negative bias from the adjusters used in kit 346 lot. Siemens recommends the transition to batches of kit 347 and above to IMMULITE / IMMULITE 1000 D-dimer, which utilize batches of unaffected adjusters.
  • Reason
    Siemens healthcare diagnostics has confirmed from internal investigations that lot 346 of the immulite® / immulite® 1000 turbo-d d-dimer kit can display a negative bias average of up to approximately 28% in patient samples. reference kit lot.
  • Action
    Field Action Code IMC 17-04 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send notification to the client.

Device

D-dimer IMMULITE / IMMULITE 1000 Technical Name: D-DÍMERO Registration Number ANVISA: 10345161779...

Manufacturer

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