Events

Rappel de Device Recall ADVIA XPT Chemistry 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, 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
    70591
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1399-2015
  • Date de mise en oeuvre de l'événement
    2015-02-11
  • Date de publication de l'événement
    2015-04-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134088
  • 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
    Electrode, ion specific, sodium - Product Code JGS
  • Cause
    Siemens healthcare diagnostics has confirmed an issue with advia chemistry xpt software version 1.0.2. the system may cause samples to remain in an inprocess state. test results on a sample that is held inprocess will not transmit to the lis. manual intervention is necessary to complete the processing of the samples that are held inprocess.
  • Action
    Siemens Healthcare Diagnostics sent Urgent Medical Device Correction Letters (dated 2/11/2015) via FedEx to the domestic consignees informing users of the software issue with ADVIA Chemistry XPT Software Version 1.0.2. The letters included work instructions to handle the bug. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. For questions about in process samples, the event message 02 981 8728, or need assistance with mitigation solutions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. Urgent Field Safety Notice Letters were sent to the foreign consignees (distribution is determined at the country level). Field service personnel were notified of the Urgent Medical Device Correction Letter.

Device

Device Recall ADVIA XPT Chemistry System
  • Modèle / numéro de série
    Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.
  • Description du dispositif
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. || The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
  • 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