Events

Rappel de Device Recall Us Diagnostic ProScreen Drugs of Abuse Cup

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 Ameditech Inc.

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
    60100
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0152-2012
  • Date de mise en oeuvre de l'événement
    2011-06-07
  • Date de publication de l'événement
    2011-11-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104433
  • 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
    Enzyme immunoassay, amphetamine - Product Code DKZ
  • Cause
    The recall was initiated because ameditech, inc. received a complaint from us diagnostics (usd) that first check drug screen cups were packaged in the proscreen cup boxes. some of us diagnostics' customers received proscreen 5-panel cups that contain first check thc cups. the recalled products are mislabeled. if the usd customer receives the firstcheck tes, there will be no instructions for use.
  • Action
    The recall communication was initiated on June 9, 2011 with Ameditech Inc. forwarding an Urgent Medical Device Recall notification with an attached Verification Form (via phone and written notification) to the affected distributor. The letter provides the distributor with an explanation of the problem identified and actions to be taken. The distributor was required to: cease distribution of the affected lot and provide remaining inventory count to Ameditech; destroy any remaining inventory of these lots and document destruction per site requirements; and ensure that all user of the device have received a copy of the Urgent Medical Device Recall. In addition, the distributor was instructed to complete and return the enclosed Verification Form with in 10 days. For any questions about the information contained in this notice, contact Ameditech at amd.complaint@alere.com or call 858-535-1968.

Device

Device Recall Us Diagnostic ProScreen Drugs of Abuse Cup
  • Modèle / numéro de série
    Lot # 102608
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including the state of Alabama.
  • Description du dispositif
    ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived || Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
  • Manufacturer
    Ameditech Inc

Manufacturer

Ameditech Inc
  • Adresse du fabricant
    Ameditech Inc, 10340 Camino Santa Fe Ste F, San Diego CA 92121-3104
  • 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