Events

Rappel de Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems

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 Ortho-Clinical Diagnostics 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
    19634
  • Date de mise en oeuvre de l'événement
    2016-11-28
  • 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
    Manufacturer has initiated a recall due to the need to clarify operator actions folloing u90-382 or 6lu cnditions codes generated by the system., if a u90-382 or 6lu condition code (i.E associated with a wash error) occurs, the condition code text located on the vitro system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios., this notification provides additional information to a product correction notification that ortho clinical diagnostics (ortho) issued in december 2015 (medsafe ref. 19634) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors. we observed an increase in wash errors for vitros chemistry products phyt slides.
  • Action
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems

Manufacturer

Ortho-Clinical Diagnostics Inc