Events

Rappel de Beckman HDL Cholesterol

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 manufacturer #1479.

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
    20115
  • Date de mise en oeuvre de l'événement
    2016-05-06
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Cause
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results., metamizole (dipyrone) has been identified as an interferent which may cause false low results in the following assays: cholesterol osr6x16, triglyceride osr6x118, uric acid osr6x98, lactate osr6x93, enzymatic creatinine osr6x204 and lipase osr6x30. this is a previously undocumented interferent., these interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter.
  • Action
    Instructions for use to be updated

Device

Beckman HDL Cholesterol
  • Modèle / numéro de série
    Model: OSR6X87, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479