Events

Rappel de Panocell-20 and Capture-R Ready-ID. 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 Seqirus Pty Ltd.

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-00305-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-03-03
  • 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-00305-1
  • 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
    The manufacturer, immucor has identified issues with panocell-20 and capture-r ready-id.For panocell-20, donor e1011 was listed as v+ (positive) on the master list supplied with this product. the donor has subsequently been tested as v - (negative). since donor e1011 is v–, cell number 11 will be nonreactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system. for capture-r ready-id, donor d1741 was listed as v+ (positive) on the master list supplied with this product. dna testing of this donor has confirmed the donor as v - (negative). since donor d1741 is v–, cell number 4 will be non-reactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system.
  • Action
    Seqirus is providing revised master lists for the affected products which correctly identify the donors as V- (negative). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 05/07/2017.

Device

Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD).Panocell-20Item Number: 5020Lot Number: 52872Cell Number: Cell #11Expiry: 3 March 2017Capture-R Ready-IDItem Number: 66214Lot Number: ID324Cell Number: Cell #4Expiry: 2 May 2017ARTG Number: 245555ARTG Number: 245555
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd