Events

Rappel de Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) Reagent

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc..

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
    71096
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1708-2015
  • Date de mise en oeuvre de l'événement
    2015-04-20
  • Date de publication de l'événement
    2015-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136080
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Cause
    Dimension vista loci thyroid stimulating hormone (tsh) lot 14237aa may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a flex well.
  • Action
    Siemens sent an Urgent Medical Device Recall notice, dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. - Review this letter with your Medical Doctor. - Discontinue use and discard your remaining inventory of the reagent lot listed in Table 1. - Indicate your replacement product needs on the attached Field Correction Effectiveness Check form and fax to (312) 275-7795 within 30 days. Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may cause.. If you have any questions, please contact your Siemens Customer Care Center Technical Solutions at 800-441-9258, or your local Siemens technical support representative.

Device

Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) Reagent
  • Modèle / numéro de série
    Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
  • Description du dispositif
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA