Events

Retiro De Equipo (Recall) de Epiclone Anti N BGR - Immunohaematology Reagent. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Seqirus Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00754-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00754-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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).
  • Modelo / Serial
    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