Events

Avis De Sécurité sur B-R-A-H-M-S Free BhCG KRYPTOR

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Thermo Fisher.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-02-18
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    We have to inform you that we observe an overestimation of approximately 10% of free bhcg concentration only in diluted samples or controls when using b-r-a-h-m-s free bhcg kryptor kit lot 09075 or 09073. this may lead to incorrect risk estimation for fetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18. as dilutions are only necessary in samples with very high concentration of free bhcg it is anticipated that only a very small number of patients may be affected by such an error in risk assessment. however, the consequences of additional or different treatment/investigation decisions need to be considered. the impact of an incorrect risk results is mitigated by the fact that free bhcg measurement is not interpreted by its own but only in conjunction with other laboratory and clinical findings as advised by labeling.

Device

B-R-A-H-M-S Free BhCG KRYPTOR
  • Modèle / numéro de série
    09075 and 09073
  • Manufacturer
    Thermo Fisher

Manufacturer

Thermo Fisher