Events

Rappel de Device Recall Specimen Gate Laboratory eReports

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 PerkinElmer Health Sciences, 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
    75817
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0902-2017
  • Date de mise en oeuvre de l'événement
    2016-12-01
  • Date de publication de l'événement
    2016-12-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151383
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Issue may cause ereports to consume an excessive amount of disk space causing the software to stop operating.
  • Action
    PerkinElmer Health Sciences issued a Medical Device Correction letter dated December 1, 2016, to all affected customers email facilitated through our PerkinElmer Software Services group located in Akron Ohio. Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures. Actions to be taken A field correction of the issue is recommended. PerkinElmer will correct the issue with an update installed through remote connection. You will be contacted by your PerkinElmer representative to make the necessary arrangements for implementing the update. In the interim period, please do not attempt to login multiple times in quick succession. Allow the software time to respond to first login command. Please contact your local PerkinElmer representative or Specimen Gate Support for further information. Other Information Please inform those affected in your organization accordingly. To comply with regulatory requirements we request that you complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 22, 2016. For questions regarding this recall call 781-663-6900.

Device

Device Recall Specimen Gate Laboratory eReports
  • Modèle / numéro de série
    Software Version 1.0
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
  • Description du dispositif
    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 || Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Adresse du fabricant
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA