Events

Safety Alert for Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANTIGEN (PSA) ANVISA Registration Number: 10345160987 Hazard Class: III Affected Model: 100 Test Kit / 500 Test Kit Serial Numbers Affected: 336; 337 and 338

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
    2072
  • Date
    2017-01-12
  • 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 the discontinuation and discontinuation of the mentioned lots and subsequent replacement request. The company does not recommend a review of previously generated results. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Reason
    Siemens identified negative bias for batches 0336 and 0337 of the 3rd generation immulite psa (prostate specific antigen) assay. research by siemens has confirmed that patient samples may display a negative mean bias of approximately -22% with a range of -16% to -27% for samples ranging from 0.08 to 16.2 ng / ml. quality controls demonstrate a negative bias similar to those found in patient outcomes. depending on the quality control ranges used in your lab, this problem may not be identified by your qa material. a preliminary investigation at siemens indicates that the root cause of the negative bias is related to the adjusters used in kit lots 0336 and 0337. however, siemens has not yet confirmed a negative bias in kit lot 0338 until now, this lot is being included in this notice because this kit has the same batches of adjusters from lot kits 0336 and 0337. subsequently, 3rd generation immulite / immulite 1000 psa batches that do not have impacted lot adjusters in the kit will not be affected.
  • Action
    Field Action BMI Code 17-05 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANT...

Manufacturer

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