Events

Rappel de Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. 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-2018-RN-00628-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-22
  • 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-2018-RN-00628-1
  • 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 remel europe ltd, part of thermo fisher scientific, has determined that thermo scientific remel salmonella paratyphi a-h stained suspension (r30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the instructions for use (ifu).
  • Action
    Thermo Fisher Scientific is requesting users:- Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.

Device

Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diag...
  • Modèle / numéro de série
    Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diagnostic medical device (IVD)Lot Numbers: 2184561, 2308897, 2228271, 2213610 & 2258333ARTG number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)Possibility of Granularity Upon Dispensing
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand