Events

Rappel de Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0

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.

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
    46740
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1462-2008
  • Date de mise en oeuvre de l'événement
    2008-01-21
  • Date de publication de l'événement
    2008-05-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68116
  • 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
    Amphetamine test system - Product Code DKZ
  • Cause
    Error message: if the positive and negative interpretation cutoff parameters (116/117) are edited after installation of the revised assay file, vrtx error #0002 in task 40 is generated and the instrument locks up when it attempts to report an axsym amphetamine/methamphetamine ii patient result.
  • Action
    Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.

Device

Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0
  • Modèle / numéro de série
    Lot Numbers: 59311P100 and 59312P100.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
  • Description du dispositif
    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
  • 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