Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2072
  • Date
    2017-01-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA