Events

Rappel de STREP A TWIST RAPID TEST DEVICE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par NOVA CENTURY SCIENTIFIC INC. A DIVISION OF TRINITY BIOTECH PLC..

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
    13126
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-09-26
  • 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
    Through testing it was determined that this product may have an elevated incidence of false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. as with all diagnostic tests all results must be interpreted together with other clinical information available to the physician. the root cause is still under investigation.

Device

STREP A TWIST RAPID TEST DEVICE
  • Modèle / numéro de série
    Model Catalog: NCS-502T (Lot serial: 9080038); Model Catalog: NCS-502T (Lot serial: 9010062); Model Catalog: NCS-502T (Lot serial: 8100040); Model Catalog: NCS-502T (Lot serial: 8100037); Model Catalog: NCS-502T (Lot serial: 0100050); Model Catalog: NCS-502T (Lot serial: 0060032); Model Catalog: NCS-502T (Lot serial: 0060010); Model Catalog: NCS-502 (Lot serial: 9010101); Model Catalog: NCS-502 (Lot serial: 1010001); Model Catalog: NCS-502 (Lot serial: 9060069); Model Catalog: NCS-502 (Lot serial: 9030135); Model Catalog: NCS-502 (Lot serial: 9030062); Model Catalog: NCS-502 (Lot serial: 0060011); Model Catalog: NCS-502 (Lot serial: 8110066); Model Catalog: NCS-502 (Lot serial: 1070036); Model Catalog: NCS-502 (Lot serial: 1040066); Model Catalog: NCS-502 (Lot serial: 1030052)
  • Description du dispositif
    NCS STREP A TWIST RAPID TEST DEVICE
  • Manufacturer
    NOVA CENTURY SCIENTIFIC INC. A DIVISION OF TRINITY BIOTECH PLC.

Manufacturer

NOVA CENTURY SCIENTIFIC INC. A DIVISION OF TRINITY BIOTECH PLC.