Events

Rappel de Device Recall UltraVision Detection System, AntiPolyvalent, AlkPhos/Fast Red (Ready to Use)

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
    60967
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1084-2012
  • Date de mise en oeuvre de l'événement
    2012-01-11
  • Date de publication de l'événement
    2012-02-22
  • 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=106998
  • 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
    Firm was notified by vendor that a component in kits was not meeting internal specifications. declination in product performance confirmed by thermo fisher.
  • Action
    Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

Device

Device Recall UltraVision Detection System, AntiPolyvalent, AlkPhos/Fast Red (Ready to Use)
  • Modèle / numéro de série
    Catalog number: TP-015-AF; Lot Number: PAF110420, Exp. 4/2012; Lot Number: PAF110503, Exp 6/2012; Lot number :PAF110722, Exp 9/2012.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
  • Description du dispositif
    UltraVision Detection System; || Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Adresse du fabricant
    Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Source
    USFDA