Events

Rappel de ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1

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

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
    92233
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-07-13
  • 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
    Affected batches are positive for antibodies to hiv 1 and/or hiv 2 despite a claim on the package insert that the product is manufactured from serum or plasma that is negative for antibodies to hiv 1 and 2. there is no impact on the performance of the affected batches and the anti-hiv 1/2 positive stock used to manufacture the accurun 51 products us treated with beta propiolactone and uv radiation to reduce virus activity minimizing any safety risk.

Device

ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1
  • Modèle / numéro de série
    Model Catalog: 2000-0041 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10164524); Model Catalog: A51-5001 (Lot serial: Batch 10164524); Model Catalog: A51-5005 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10231486); Model Catalog: 2000-0041 (Lot serial: Batch 10231486); Model Catalog: A51-5001 (Lot serial: Batch 10231486); Model Catalog: A51-5005 (Lot serial: Batch 10231486); Model Catalog: 2000-0040 (Lot serial: Batch 10164525); Model Catalog: 2000-0041 (Lot serial: Batch 10164525); Model Catalog: A51-5001 (Lot serial: Batch 10164525); Model Catalog: A51-5005 (Lot serial: Batch 10164525); Model Catalog: 2000-0040 (Lot serial: Batch 10231487); Model Catalog: 2000-0041 (Lot serial: Batch 10231487); Model Catalog: A51-5001 (Lot serial: Batch 10231487); Model Catalog: A51-5005 (Lot serial: Batch 10231487)
  • Description du dispositif
    ACCURUN 51 Multi-Marker Hepatitis Positive Control;ACCURUN 51 Multi-Marker Hepatitus Positive Control
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Adresse du fabricant
    EDMONTON
  • Société-mère du fabricant (2017)
    Diploma Plc
  • Source
    HC