Events

Rappel de Device Recall Estrogen Receptor AB11 (Clone ID5)

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 Lab Vision Corporation.

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
    67065
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0775-2014
  • Date de mise en oeuvre de l'événement
    2013-12-06
  • Date de publication de l'événement
    2014-01-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124646
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Cause
    Reports that the product is not performing as expected. in house testing showed no staining on breast cancer tissues.
  • Action
    Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.

Device

Device Recall Estrogen Receptor AB11 (Clone ID5)
  • Modèle / numéro de série
    PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
  • Description du dispositif
    Estrogen Receptor AB-11 (Clone ID5) || Mouse Monoclonal Antibody || 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA || Thermo Fisher Scientific || Anatomical Pathology || Tudor Rd., Manor Park || Rancorn, Cheshire WA7 1TA UK || Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Adresse du fabricant
    Lab Vision Corporation, 46117 Landing Pkwy, Fremont CA 94538-6407
  • Source
    USFDA