Events

Rappel de Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides

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
    20995
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • Cause
    The manufacturer has identified the potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1 1/2 to 8 hours then placed on the analyzer. the manufacturer has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit., follow up and resolution november 2017, the manufacturer is introducing vitros electrolyte reference fluid (erf) 300 and vitros electrolyte reference fluid (erf) 800 with a revised formulation that:, 1. restores the na+ cartridge warm-up protocol to 90 minutes when taken from the refrigerator (120 minutes from the freezer) as defined in the vitros na+ slides instructions for use., 2. reformulated erf helps to reduce sources of variability (e.G., calibration variability) observed when using vitros na+ slides.
  • Action
    Manufacturer to issue advice regarding use

Device

Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides
  • Modèle / numéro de série
    Model: , Affected: Generation (GEN) 1 through 6, 30 through 40, 44 through 49
  • Manufacturer
    Ortho-Clinical Diagnostics Inc

Manufacturer

Ortho-Clinical Diagnostics Inc