Events

Rappel de PHADIA 100 SYSTEM - ALLERGENS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHADIA AB.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66405
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2018-01-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Somagen diagnostics along with thermofisher scientific would like to notify you of an urgent recall and backorder of immunocap allergen c5 ampicilloyl product code 14-4450-01 and immunocap allergen c6 amoxicilloyl product code 14-4451-01. an internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. there is a possibility that samples with a low positive concentration may be incorrectly reported as negative. any reported test results below the assay limit of qualification (loq) should be disregarded as these results may be invalid. no complaints or injuries to patients have been reported.

Device

PHADIA 100 SYSTEM - ALLERGENS
  • Modèle / numéro de série
    Model Catalog: 14-4451-01 (Lot serial: 991D7); Model Catalog: 14-4451-01 (Lot serial: 991DC); Model Catalog: 14-4451-01 (Lot serial: 991DB); Model Catalog: 14-4451-01 (Lot serial: 991D8); Model Catalog: 14-4451-01 (Lot serial: 991D9); Model Catalog: 14-4450-01 (Lot serial: 990DT); Model Catalog: 14-4450-01 (Lot serial: 990DS); Model Catalog: 14-4450-01 (Lot serial: 990DU); Model Catalog: 14-4450-01 (Lot serial: 990DV); Model Catalog: 14-4451-01 (Lot serial: 991DA); Model Catalog: 14-4450-01 (Lot serial: 990DX); Model Catalog: 14-4450-01 (Lot serial: 990DY); Model Catalog: 14-4450-01 (Lot serial: 990DZ); Model Catalog: 14-4450-01 (Lot serial: 990DW)
  • Description du dispositif
    ImmunoCAP Allergen c6 Amoxicilloyl;ImmunoCAP Allergen c5 Ampicilloyl
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB