Events

Rappel de VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. 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 Ortho-Clinical Diagnostics.

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-2016-RN-00420-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-12
  • 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-2016-RN-00420-1
  • 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
    A vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results.Scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a.There is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury.
  • Action
    Ortho is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. It is recommended to discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. Ortho will be providing users with a software update (software version 3.2.3) as a permanent correction. This can be automatically downloaded for systems connected to e-Connect or software kits provided for systems not connected to e-Connect. This action has been closed-out on 20/02/2017.

Device

VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 an...
  • Modèle / numéro de série
    VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostics System, software version 3.2.2 and belowProduct Code: 6802783Unique Device ID: 10758750002979VITROS 5600 Integrated System, software version 3.2.2 and belowProduct Code: 6802413Unique Device ID: 10758750002740ARTG Number: 180199
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics