Events

Rappel de Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter 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-2017-RN-00679-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-01
  • 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-2017-RN-00679-1
  • 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
    Beckman coulter has determined through customer feedback and an internal investigation that the four (4) access immunoassays listed are susceptible to biotin interference. during interference testing, the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population.Specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. the higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of these four affected access assays and may cause false low results (for the access gi monitor and thyroglobulin assays) and false high results (for the access free t4 and total t3 assays).
  • Action
    Beckman Coulter will update the "Limitations" section of the Access Total T3, Thyroglobulin, Free T4, and GI Monitor Instructions for Use with this biotin interference information. Users are requested to interpret the results in light of the total clinical presentation of the patient (including symptoms, clinical history, data from additional tests, and other appropriate information).

Device

Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitr...
  • Modèle / numéro de série
    Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems)Access Total 3Reference Number: 33830Access ThyroglobulinReference Number: 33860Access Free T4Reference Number: 33880Access GI MonitorReference Number: 387687All LotsARTG Numbers: 213975 and 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd