Events

Rappel de Streptex Rapid Latex Agglutination Test. 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-01059-1
  • 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-01059-1
  • 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 themo fisher has confirmed that extraction enzyme lots 1960420 and1960621 (contained in the product lots 1959920, 1987862 and 2106328) may provide atypical performance when used with streptex g latex reagent. false positive results may be seen within the one minute reaction time detailed in the instruction for use. continued use of these lots of extraction enzyme with g latex reagent (only) may result in incorrect results reporting.
  • Action
    Users are to inspect stocks and remove from further use all units from the affected batch numbers. Complete the Facsimile Reply Form supplied with the customer letter and fax it to the sponsor for a credit note will be issued. Requirement for a review of patient results should be at the discretion of the laboratory director.

Device

Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)Product Number: R30950501Lot Numbers: 1959920, 1987862 and 2106328ARTG Number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand