Events

Rappel de Device Recall Perkin Elmer Genetic Screening Processor (GSP)

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.

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
    62512
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2121-2012
  • Date de mise en oeuvre de l'événement
    2012-06-27
  • Date de publication de l'événement
    2012-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110801
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Cause
    Contamination from gsp shaker unit results in decreased signal activity of assay measurements for genetic screening for neonatal irt, tsh and irt.
  • Action
    PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. Technical.Support@PerkinElmer.com

Device

Device Recall Perkin Elmer Genetic Screening Processor (GSP)
  • Modèle / numéro de série
    Serial Numbers: 20210001 through 20210078
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
  • Description du dispositif
    Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Adresse du fabricant
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA