Events

Rappel de Siemens Dimension TNI CAL

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
    66364
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1926-2014
  • Date de mise en oeuvre de l'événement
    2013-09-17
  • Date de publication de l'événement
    2014-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122157
  • 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
    Calibrator, secondary - Product Code JIT
  • Cause
    Siemens dimension loci tni troponin i calibrator lot 3dd007 may demonstrate an average upward shift of 24% in qc and patient results following calibration.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised immediate discontinuation of use and discard of the affected device. Please complete the attached Effectiveness Check form and fax it to the Siemens Customer Care Center at (302) 631-8467 to indicate that you have received this information. Also, please indicate any replacement product required. Please contact Siemens Customer Care Center- Technical Solutions at (800) 441 9250 if you are aware of any adverse event that occurred as a consequence of this issue, or for immediate product needs. Please retain this letter with your laboratory records, and forward this Jetter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens Dimension TNI CAL
  • Modèle / numéro de série
    Lot Number - 3DD007
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution: US Nationwide including Puerto Rico
  • Description du dispositif
    Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. || The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
  • 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