Events

Rappel de Device Recall TDx/TDxFLx Methotrexate II

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 Abbott Diagnostic International, Ltd..

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
    37728
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1056-2007
  • Date de mise en oeuvre de l'événement
    2007-03-20
  • Date de publication de l'événement
    2007-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51394
  • 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
    Reagent - Product Code LAO
  • Cause
    Incorrect configuration: kits contain reagent bottles in the order s-w-t-p instead of the correct order, w-s-t-p.
  • Action
    The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records.

Device

Device Recall TDx/TDxFLx Methotrexate II
  • Modèle / numéro de série
    Lot Number: 45050Q100
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    World wide Distribution : USA including states of AR, CA, CO, CT, DE, FL,GA, ID, IL, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NJ, NY, NC,NV, OH, SC, PA, RI, TN, TX, UT, WA, WI, WV, Hawaii, Washington DC, and Puerto Rico. Countries of : Canada, Mexico, Venezuela, Columbia, Chile, Brazil, Germany, Japan, Hong Kong, Australia and New Zealand
  • Description du dispositif
    TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA