Events

Safety Alert for Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registration 10345160643 /// Immulite 2000 System, registration 10345160645 /// Immulite Immunoassay System 10345161653. The identification of the affected products are listed in the Chart in Attachment.

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 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
    1636
  • Date
    2015-07-10
  • 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
    According to the holder due to the problem in the conductive material, measurement errors may occur at the level even though there is the minimum volume of sample present in the sample cup or tube. . An error message may appear if there is not enough sample in the microsample tube or sample cup
  • Reason
    The conductive material of the immulite / immulite 1000 sample cup holders and the immulite 2000 / immulite 2000xpi microsample inserts, both used for sample processing, do not meet the specification to facilitate measurement of the liquid and sample level respectively (sensor error). level).
  • Action
    According to the holder of the registration, for IMMULITE / IMMULITE 1000 the problem can be solved by adding more sample to the sample cup. For IMMULITE 2000 / IMMULITE 2000XPi the problem can be solved by adding more sample to the micro-sample tube. The company will make a field correction of the analyzers with replacement of the units. See affected lots in the ANNEX. Upon receiving the new sample cup Holder or microsample insert discard the products from the problematic lots.

Device

Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registrati...

Manufacturer

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