Events

Rappel de Chemistry 1 Calibrator (used with the Dimension Vista System). 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 Siemens Healthcare 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-2016-RN-01243-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-22
  • 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-01243-1
  • 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
    Siemens healthcare diagnostics has identified that affected lots may produce depressed results with current lots of calcium reagent. although the affected lots are expired, the calcium calibration interval is 90 days; therefore, it is possible that calibrations using the affected calibrator lots are active. average bias for current calcium (ca) reagent lots ranges from -0.08 mmol/l to -0.2 mmol/l with a maximum individual sample bias of -0.3 mmol/l. biases were calculated based on the differences observed when comparing to results generated using nist standard material for calibration. biases were similar for urine and serum samples and were not dependent upon calcium concentration. when this issue occurs, the potential exists for misinterpretation of calcium levels, which may affect consideration of intervention.
  • Action
    Siemens is advising user that if they have an active calibration of Calcium (CA) that used calibrator lot 5GM081 or 5GM082, recalibrate CA with an alternate lot of CHEM 1 CAL. Siemens is not recommending a review of previously generated results.

Device

Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical dev...
  • Modèle / numéro de série
    Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD)Catalogue Numbers: KC110, KC110BSiemens Material Numbers: 10445169, 10716281Lot Numbers: 5GM081, 5GM082Expiry: 1 July 2016ARTG Number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA