Events

Rappel de Device Recall ARCHITECT i System Assay CDROM, U.S. Version 21.0

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 Laboratories MPG.

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
    37070
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0413-2007
  • Date de mise en oeuvre de l'événement
    2007-01-02
  • Date de publication de l'événement
    2007-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49855
  • 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 analyzer - Product Code JJI
  • Cause
    The architect ausab and architect anti-hcv assay parameter default interpretation screens when using architect assay cd-rom us version 06e58-21 does not align with the result interpretation options in the architect ausab reagent package insert (pi) 34-4162/r1 and architect anti-hcv pi 34-4152/r1.
  • Action
    On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.

Device

Device Recall ARCHITECT i System Assay CDROM, U.S. Version 21.0
  • Modèle / numéro de série
    list number 06E58-21, version 21.0, lot 45572P100
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Adresse du fabricant
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA