Events

Rappel de SIMPLEXA FLU A/B & RSV DIRECT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIO NUCLEAR 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
    27527
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2014-01-20
  • 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
    Focus diagnostics has received some customer complaints of simplexa flu a/b & rsv lots with sporadic false positive rsv signals which may result in a higher rsv false positive rate. the potential false positive rsv results are unpredictable within the identified lots and may not be easily identified during testing. this issue is only seen with the rsv (m gene) fluorescent probe-primer. the influenza a/b results are not impacted since the fluorescent probe-primers to detect influenza a/b viruses are different than those detecting rsv.

Device

SIMPLEXA FLU A/B & RSV DIRECT
  • Modèle / numéro de série
    Model Catalog: MOL2650 (Lot serial: 24536); Model Catalog: MOL2650 (Lot serial: 24495); Model Catalog: MOL2650 (Lot serial: 24493); Model Catalog: MOL2650 (Lot serial: 24807); Model Catalog: MOL2650 (Lot serial: 24797); Model Catalog: MOL2650 (Lot serial: 24788); Model Catalog: MOL2650 (Lot serial: 24773); Model Catalog: MOL2650 (Lot serial: 24732); Model Catalog: MOL2650 (Lot serial: 24605); Model Catalog: MOL2650 (Lot serial: 24603); Model Catalog: MOL2650 (Lot serial: 24591); Model Catalog: MOL2650 (Lot serial: 24535)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Description du dispositif
    SIMPLEXA FLU A/B & RSV DIRECT
  • Manufacturer
    BIO NUCLEAR DIAGNOSTICS INC.

Manufacturer

BIO NUCLEAR DIAGNOSTICS INC.