Events

Rappel de Device Recall E.faecalis/OE PNA Fish

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 AdvanDx, 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
    56064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2315-2010
  • Date de mise en oeuvre de l'événement
    2010-06-08
  • Date de publication de l'événement
    2010-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92578
  • 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
    fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis - Product Code OAH
  • Cause
    Some strains of streptococus anginosus cross-reach with e. faecalis/oe pna fish to produce a false positive green signal.
  • Action
    The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under "limitations" to include the statement "some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert. If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email techsupport@advandx.com.

Device

Device Recall E.faecalis/OE PNA Fish
  • Modèle / numéro de série
    Catalog number KT003
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Description du dispositif
    E.faecalis/OE PNA FISH || Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
  • Manufacturer
    AdvanDx, Inc.

Manufacturer

AdvanDx, Inc.
  • Adresse du fabricant
    AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
  • Société-mère du fabricant (2017)
    Advandx, Inc.
  • Source
    USFDA