Events

Rappel de VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry System

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-2014-RN-00502-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-07
  • 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-2014-RN-00502-1
  • 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
    This recall action has been initiated by ortho-clinical diagnostics, inc. (ocd) due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros® systems listed. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result.
  • Action
    Ortho-Clinical Diagnostics (OCD) will resolve this issue in a future software release. To assist in the interim OCD is providing a procedure for reviewing VITROS chemistry results and MW codes. This action has been closed-out on 11/02/2016.

Device

VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VI...
  • Modèle / numéro de série
    VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry SystemVITROS 4600 Chemistry SystemProduct Code: 6802445Affected Software Versions: 3.0 and lowerVITROS 5600 Integrated SystemProduct Code: 6802413Affected Software Versions: 3.0 and lowerVITROS 5,1 FS Chemistry SystemProduct Codes: 6801375, 6801890Affected Software Versions: 2.7 and lowerMultiple assays affected
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics