Events

Retiro De Equipo (Recall) de Abbott Acetaminophen Reagent

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Sekisui Diagnostics P.E.I. Inc.

¿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
    18518
  • Fecha de inicio del evento
    2015-05-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Causa
    The current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 mcg/ml (688 umol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool., based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 mcg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool., the package insert is being updated accordingly based on these results.
  • Acción
    Product to be destroyed

Device

Abbott Acetaminophen Reagent
  • Modelo / Serial
    Model: List Number: 2K99-20, Affected: Lots: 4579UQ04, 46121UQ07, 46561UQ08, 46207UQ09, 46953UQ12
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc

Manufacturer

Sekisui Diagnostics P.E.I. Inc