Events

Rappel de Abbott Acetaminophen Reagent

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Sekisui Diagnostics P.E.I. Inc.

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
    18518
  • Date de mise en oeuvre de l'événement
    2015-05-14
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Cause
    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.
  • Action
    Product to be destroyed

Device

Abbott Acetaminophen Reagent
  • Modèle / numéro de série
    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