Events

Rappel de CIDEX OPA Solution Test Strips

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2015-RN-00298-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-04-01
  • 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-2015-RN-00298-1
  • 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
    The manufacturer has determined that shelf life data for the cidex opa solution test strips is effective for only 10 months of the test strip’s labeled 12-month shelf life. there is no potential risk to patient safety, as test strips used at the end of shelf life would indicate a false negative (e.G. “fail” result for solution above the minimum effective concentration). this issue could be observed during either qc testing of the test strips prior to use (in accordance with the instructions for use) or during testing of cidex opa solution when the test strips are near the end of shelf life. there was no evidence that a false positive (e.G. a “pass” result for solutions below the mec) would occur.A corrective action is in place to update the shelf life of the cidex® opa solution test strips from 12 months to 10 months.
  • Action
    Customers are requested to update the expiry date from 12 to 10 months. This action has been closed-out on 03/03/2016.

Device

CIDEX OPA Solution Test Strips

Manufacturer

Johnson & Johnson Medical Pty Ltd