Events

Recall of Device Recall Us Diagnostic ProScreen Drugs of Abuse Cup

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ameditech Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60100
  • Event Risk Class
    Class 2
  • Event Number
    Z-0152-2012
  • Event Initiated Date
    2011-06-07
  • Event Date Posted
    2011-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104433
  • Notes / Alerts
    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.
  • Extra notes in the data
    Enzyme immunoassay, amphetamine - Product Code DKZ
  • Reason
    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
  • Model / Serial
    Lot # 102608
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the state of Alabama.
  • Product Description
    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
  • Manufacturer Address
    Ameditech Inc, 10340 Camino Santa Fe Ste F, San Diego CA 92121-3104
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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