Events

Rappel de Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)

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
    56320
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2424-2010
  • Date de mise en oeuvre de l'événement
    2010-03-05
  • Date de publication de l'événement
    2010-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93227
  • 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
    Two lots may be contaminated with ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
  • Action
    Thermo Fisher Scientific issued an "Advisory Notice" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken. Customers were instructed to: 1) discard the affected lots, and 2) retest specimens using a replacement lot supplied by the firm, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 International distributors were instructed to: 1) place the affected lots and replace with a replacement lot supplied by the firm, and 2) provide customers with copies of the customer letter, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.

Device

Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)
  • Modèle / numéro de série
    lots 9104S911A through 9104S911E and 9104S1001A, Catalog number RM-910, Expiration dates November 2011 and January 2012.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and Turkey.
  • Description du dispositif
    NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Adresse du fabricant
    Lab Vision Corporation, 47777 Warm Springs Blvd, Fremont CA 94539-7470
  • Source
    USFDA