Events

Rappel de SCREENERS Dip Drug Test

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
    58716
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2670-2011
  • Date de mise en oeuvre de l'événement
    2011-04-26
  • Date de publication de l'événement
    2011-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100133
  • 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's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.
  • Action
    Ameditech, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter requested the customer to: (1) Cease distribution of the affected lot and provide remaining inventory count to Ameditech. (2) Destroy any remaining inventory of these lots and document destruction per your site requirements. (3) Ensure that all users of the device receive a copy of the Urgent Medical Device Recall letter. A recall verification form was attached to the letter to be completed and returned by the customer via fax at 1-858-677-0243. Any questions about the information contained in the recall notice should be directed to Ameditech at amd.complaint@alere.com or call 858-535-1968.

Device

SCREENERS Dip Drug Test
  • Modèle / numéro de série
    Lot Numbers: 110669 & 100093
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 || The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. 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 meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.
  • 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