Events

Rappel de Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Thermo Fisher Scientific Australia & New Zealand.

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
    RC-2017-RN-01103-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-23
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01103-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    An internal technical investigation by thermo fisher scientific has confirmed that specific lots of remel wellcolex colour shigella reagent may notagglutinate in the presence of positive cultures. a negative result indicates that the organisms under test do not belong to the serotypes of shigella species covered by the reagents. latex reagent 2 is used to identify common serotypes of s. dysenteriae and s. boydii. continued use of these lots may result in a failure to correctly identify s. boydii. s.Dysenteriae results are unaffected. latex reagent 1 continues to perform correctly and will identify common serotypes of s. sonnei and s. flexneri.
  • Action
    1. Inspect your stocks and remove from further use of all units from the impacted batch number, then complete and return the Facsimile Reply Form supplied with the customer letter. 2. If any recalled stock has been transferred from your laboratory to another, inform that laboratory of the recall action.

Device

Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)Product Code: R30858401Lot Numbers: 1991413, 2130764, 2110576, and 2143554ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand