Events

Avis De Sécurité sur Anti-M Monoclonal Blood Grouping 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 Millipore (UK) Ltd.

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
  • 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
    Millipore (uk) ltd is issuing this field safety notice for the bioscot anti-m monoclonal blood grouping reagent lots identified in both tables 1 and 2 (the “product”). the product lots detailed in table 1 are showing weak and /or negative results when testing m+ red blood cells in line with the method described in the instructions for use (ifu). the product lots detailed in table 2 have not displayed the same weak reactions at this time, however millipore (uk) ltd have made the decision to include all lots of product code ne in this field safety notice as a precaution. .

Device

Anti-M Monoclonal Blood Grouping Reagent

Manufacturer

Millipore (UK) Ltd