Events

Rappel de Device Recall Architect AUSAB REAGENT Kit

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
    37961
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1096-2007
  • Date de mise en oeuvre de l'événement
    2007-05-14
  • Date de publication de l'événement
    2007-07-24
  • 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=52466
  • 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
    in vitro diagnostic - Product Code LOM
  • Cause
    During an internal study, the architect ausab assay was found to read preparations of the who standard up to 53% higher than the who assigned value. this has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.
  • Action
    All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form > Product Information Letter to be included in new kits to be distributed. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed to: Please follow their laboratory procedures for evaluation of these results Disregard the automated interpretation of results for low-level reactive samples. A customer reply form will accompany the Product Correction letter. Effectiveness Check Depth: 100% of customers receiving the Product Correction letter. The start date of communication was May 14,2007.

Device

Device Recall Architect AUSAB REAGENT Kit
  • Modèle / numéro de série
    PRODUCT LIST NUMBER = 1L82-25 Lot numbers = 48453Q100 Exp date 03/23/2008, 46687Q100 Exp date 05/01/2007, 44801Q100 Exp date 02/28/2007, 42577Q100 Exp date 12/05/2006, and 43270Q100 Exp date 01/06/2007
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Description du dispositif
    ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.
  • 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