Events

Rappel de ARCHITECT i System Assay CDROM WW (excluding USA accounts)

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.

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
    45397
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0299-2008
  • Date de mise en oeuvre de l'événement
    2007-09-18
  • Date de publication de l'événement
    2008-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-11-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65375
  • 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
    Chemiluminescent Microparticle Immunoassay (CMIA) - Product Code LOJ
  • Cause
    The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/ml) for the architect afp assay file for the architect afp non-u.S. product. the assay labeling indicates that the limit flag should be set no lower than 20 ng/ml.
  • Action
    Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. 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 testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.

Device

ARCHITECT i System Assay CDROM WW (excluding USA accounts)
  • Modèle / numéro de série
    LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts.
  • Description du dispositif
    ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Adresse du fabricant
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA