Events

Rappel de Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Randox Australia Pty Ltd.

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
    RC-2018-RN-00239-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00239-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Randox have identified that the reagent triglycerides can cause elevated lipase results when the lipase reagent is run after triglycerides within the same run. this can affect a qc or patient sample test result. randox have now released further steps for contamination avoidance with the lipase assay on rx instruments. users should refer to the instrument testing order specifically arranging chemistries so that lipase and triglycerides are the last two chemistries in the test running order.In the event of an extremely elevated lipase result, cuvette maintenance steps should be performed as recommended for each rx system. the sample should then be re-tested running the lipase assay in isolation.
  • Action
    Randox is advising customers and distributors to amend their test running order and update the RX analyser operator manual with the revised information. Updated IFU's will be provided to users. In the event of an extremely elevated Lipase result, cuvette maintenance steps should be performed as recommended for each RX system. The sample should then be re-tested running the Lipase assay in isolation.

Device

Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Randox Lipase Reagents for use on RX instruments. An in vitro diagnostic medical device (IVD)Catalogue Numbers: LI7979, LI8050ARTG Number: 199615(Randox Australia - Clinical chemistry enzyme IVDs)
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA