Events

Avis De Sécurité sur ID-DiaCell

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 Bio-Rad Laboratories.

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
    2017-09-27
  • 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 been made aware that the above-mentioned products of cells may show antibody of (antibody undetermined specificity) undetermined specificity (aus) in iat method which are not confirmed by further testing's. the company is fully aware of the magnitude of this problem and the level of distress that this is causing in the field. a risk assessment has been performed and no patient risk has been identified. a team of experts is currently working on this issue äs an absolute priority. we will let you know about any updates of this issue.

Device

ID-DiaCell
  • Modèle / numéro de série
    ID-DiaCell 1-11-111 ID-DiaCell A1A2B/I-II-III ID-DiaCell 1-11 ID-DiaCell 1-11-111 Asia ID-DiaPanel ID-DiaPanel 6 Plus Cat. ref. n° 004310 003618 003613 003614 004114 004414
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories