Events

Recall of Device Recall Alere iScreen Dx Urine Drug Screen Card

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
    79549
  • Event Risk Class
    Class 3
  • Event Number
    Z-1542-2018
  • Event Initiated Date
    2017-12-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162621
  • 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
    U.V. Spectrometry, tricyclic antidepressant drugs - Product Code LFH
  • Reason
    The kit box label incorrectly identifies phencyclidine (pcp), where it should list tricyclic antidepressants (tca) as one of the 10 drug analytes included in the kit box.
  • Action
    Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.

Device

Device Recall Alere iScreen Dx Urine Drug Screen Card
  • Model / Serial
    Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
  • Product Description
    Alere iScreen Dx Urine Drug Screen Card
  • Manufacturer
    Ameditech Inc

Manufacturer

Ameditech Inc
  • Manufacturer Address
    Ameditech Inc, 9940 Mesa Rim Rd, San Diego CA 92121-2910
  • Source
    USFDA