Events

Rappel de EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

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
    75862
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0897-2017
  • Date de mise en oeuvre de l'événement
    2016-12-05
  • Date de publication de l'événement
    2016-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151470
  • 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
    Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System - Product Code PJI
  • Cause
    Unique device identifier (udi) is missing from outer kit box label.
  • Action
    Customers were notified of the recall via email on December 5, 2016. Technical Support will ensure the customers receive the Recall Letter and understand the recommended actions. Customers were asked to retain this Medical Device Correction in your laboratory documentation until the affected lot inventory is either depleted or reaches expiration and to 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 29, 2016.

Device

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determi...
  • Modèle / numéro de série
    Lot Number: 1065060401
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    MA, AK
  • Description du dispositif
    EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Adresse du fabricant
    PerkinElmer Health Sciences, Inc.
  • Société-mère du fabricant (2017)
    Perkin Elmer Inc.
  • Source
    USFDA