Events

Rappel de Device Recall ADVIA Centaur TniUltra" Assay

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
    74036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2041-2016
  • Date de mise en oeuvre de l'événement
    2016-05-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146020
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Cause
    Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin.
  • Action
    Siemens Healthcare sent an Urgent Medical Device Correction letter dated May 2, 2016, The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to continue use of the affected product, review the letter with their doctor, complete and return the Field Correction Effectiveness Check attached to the letter. If customers received any complaints of illness or adverse events associated wit the affected product they should immediately contact their local Siemens Customer Care Center or their local Siemens technical support representative. Customers with questions should contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.

Device

Device Recall ADVIA Centaur TniUltra" Assay
  • Modèle / numéro de série
    All in date lots
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
  • Description du dispositif
    Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems || Cat No. 02789602/SMN 1031 7708 (100 test) || Cat No. 02790309/SMN 10317709 (500 test)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA