Events

Rappel de Genetic Screening Processor

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 LAS, 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
    60390
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0603-2012
  • Date de mise en oeuvre de l'événement
    2011-10-24
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105229
  • 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
    Malfunction of the gsp disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. this may cause a false negative screening result being reported for 17-ohp, resulting in failure to identify cases of congenital adrenal hyperplasia (cah).
  • Action
    Recall (correction) letters were sent to all customers on October 24, 2011. An improved disk remover design is under development to eliminate the reported problem. Until the final field correction is available, customers should follow the precautions provided. The needed protocol update will be performed by the local service engineer. If customers observe an increase in the occurrence of the problem, the laboratory should contact their local PerkinElmer representative.

Device

Genetic Screening Processor
  • Modèle / numéro de série
    Product Code 2021-0010
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of: Missouri, Florida, Texas, Oregon, Alabama, Louisiana, New Jersey, Georgia, Virginia, Kentucky and the countries of: Australia, Belgium, Brazil, Egypt, France, Germany, Italy, Netherlands, Norway, Qatar, Saudi MOH, Switzerland, and the UK.
  • Description du dispositif
    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put 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 chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
  • Manufacturer
    PerkinElmer LAS, Inc

Manufacturer

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