Events

Rappel de Device Recall ADVIA Centaur Immunoassay System

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.

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
    69084
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2715-2014
  • Date de mise en oeuvre de l'événement
    2014-08-19
  • Date de publication de l'événement
    2014-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129600
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    The firm has identified an issue with patient demographic information sent to the lis from the advia centaur/advia centaur xp immunoassay systems. siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the lis is merged with the next order. this issue can occur when the lis data buffer on the advia centaur system becomes full.
  • Action
    Siemens sent an Urgent Medical Device Correction Letter dated August 19, 2014, via Fed Ex to US customers and via email to regional countries for implementation outside the US (OUS). The letter identified the product the problem and the action needed to be taken by the customer. The letters inform the customers of the issue and specific actions to be taken if the instrument is interfaced to an LIS system that transmits patient demographics with each order. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. Please complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed form to the Customer Care Center at (302) 631-7597. If you have any questions, contact your local Siemens technical support representative

Device

Device Recall ADVIA Centaur Immunoassay System
  • Modèle / numéro de série
    All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.
  • Description du dispositif
    ADVIA Centaur Immunoassay System (including refurbished units), || This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA