Events

Rappel de Bond ReadyToUse Primary Antibody Thyroid Transcription Factor1

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 Leica Microsystems, 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
    56406
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2497-2010
  • Date de mise en oeuvre de l'événement
    2010-08-02
  • Date de publication de l'événement
    2010-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93513
  • 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
    Immunohistochemistry Reagents And Kits - Product Code NJT
  • Cause
    In combination with a sensitive polymer detection system, the ttf-1 antibodies may stain additional tumor types other than is currently indicated on the instructions for use.
  • Action
    Leica Microsystems sent Medical Device Field Correction letters dated 7/28/10 to the affected customers via first class mail on the same date, informing them that in combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the Instructions for Use. Currently they state that lung and thyroid tumors may stain, but Leicas investigation further characterized the expression of the TTF-1 antigen and it may also be present in other tumors, e.g. thymomas. Customers who have received the affected lot numbers of the three products were requested to refer to the new Instructions for Use to review the amendments made to the Results Expected via the following links: http://bsd.leica-microsystems.com/pdfs/products/ttf-1-ce.pdf; http://bsd.leica-microsystems.com/pdfs/products/ttf-1-l-ce.pdf; and http://bsd.leica-microsystems.com/pdfs/products/pa0364.pdf; The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

Device

Bond ReadyToUse Primary Antibody Thyroid Transcription Factor1
  • Modèle / numéro de série
    Catalog #PA0364, lot numbers 05918, 06912, 07104, 08679, 09261, 10480, 10903
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of human thyroid transcription factor-1 in formalin-fixed, paraffin- embedded tissue by immunohistochemical staining using the automated Bond system; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom; Catalog No.: PA0364
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Adresse du fabricant
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA