Events

Rappel de Epiclone Anti N BGR - Immunohaematology 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 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-00754-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-30
  • 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-00754-1
  • 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
    Seqirus received a report from a customer that lot 009934602 presented false positive results during pre-acceptance testing (cells known to be n negative phenotype presented positive results during tube testing). this was subsequently confirmed to have occurred for multiple customers.Additional customer feedback was also received for a separate epiclone anti n lot (009934501) where the customer reported the product to be “uncharacteristically sticky”, causing red cells to adhere to the inner surfaces of the tube (tube testing technique), resulting in difficulty to confirm whether the reaction produced a positive or negative result.Following these customer reports, investigational testing on all epiclone lots within expiry was performed, which confirmed that epiclone anti n lots 009934401, 009934501, 009934602 and 009934701 are capable of presenting false positive results against certain n negative samples.
  • Action
    1.Quarantine all affected units from further use. 2. Package all quarantined units and label “For Drug Recall Attention (Authorised Recall Officer)” 3. Mark on the outside of each package the name of the organisation or institution returning the product. 4. Complete the Facsimile/Email Reply Form supplied with the customer letter and fax/email back to Seqirus Customer Service so that they may arrange for affected stock to be recovered, including if no product is in stock. 5. Seqirus will provide replacement of returned stock once alternative product is available. 6. Review previous results generated with the affected lot numbers as required.

Device

Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD).Item Code: 00990501Lot Numbers: 009934401, 009934501, 009934602 and 009934701ARTG Number: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd