Events

Avis De Sécurité sur Kleihauer kit fixing reagent and elution reagent

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 IMMUCOR Medizinische Diagnostik GmbH.

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
    2016-12-09
  • 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
    The reports are of inconsistent staining of cells and false positives reactivity with negative control samples. the reports indicate the stain is not sufficiently removed from the adult cells during the elution step; therefore it is difficult to distinguish fetal cells from the adult cells. a false positive reaction with the negative control invalidates the test results and a repeat of the test is needed. such repeat of testing may lead to delay in analysis of patient results and ultimately delay in patient treatment. .

Device

Kleihauer kit fixing reagent and elution reagent

Manufacturer

IMMUCOR Medizinische Diagnostik GmbH