Events

Rappel de ADVIA 560 Hematology Systems

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
    75652
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0723-2017
  • Date de mise en oeuvre de l'événement
    2016-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150989
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    Siemens is investigating an issue which may cause an incorrect result to be reported. siemens received two reports of multiple discordant records for the same sample id in the advia 560 hematology system database that occurred during the installation of the systems. the database should only contain one record of a sample id number for any given time and date. if there are multiple records for the same sample id, it is possible that multiple results may be manually or automatically sent to the laboratory information system (lis), printed or displayed on the results report screen.
  • Action
    An Urgent Medical Device Correction Letter HI17-02.A.US (dated October 21, 2016) and Response Form were sent to US Customers via Federal Express. An Urgent Field Safety Notice was sent to customers outside the US on October 21, 2016, (distribution is determined at the country level). The letters instruct customers to contact their local Siemens technical support representative if they obtain multiple results for one Sample ID. It also informs the customer what to do if the ADVIA 560 Hematology System generates any of the six error messages listed in the letter. For further questions, please call (312) 275-7795.

Device

ADVIA 560 Hematology Systems
  • Modèle / numéro de série
    All serial numbers of ADVIA 560 Hematology Systems
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of : Angola, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Japan, Kenya, Malaysia, Mexico, Myanmar, Netherlands, Norway, Pakistan, Portugal, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, Uganda, United Kingdom, Vietnam.
  • Description du dispositif
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA