Events

Rappel de Vitros Performance verifier 1

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
    18611
  • Date de mise en oeuvre de l'événement
    2015-06-03
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Cause
    The manufacturer has observed a positive bias with the first slide used from a cartridge that has been stored in the slide supply. the bias has been observed with multiple fluids across multiple gens and coating of slides and across the 5,1.Fs, 4600 amd 5600 analyzer platforms. the frist slide bias may occur when a cartridge is loaded on an analyzer and is not used for approximately 5-14 days., ocd has revised the range of means for vitros performance verifier1 for unconjugated biirubin (bu) only.
  • Action
    Manufacturer to issue advice regarding use

Device

Vitros Performance verifier 1
  • Modèle / numéro de série
    Model: 8067324, Affected: Lot Numbers: A3823 C4084 Q2961 T3161 V3297 and X3569
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479