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
    77702
  • Event Risk Class
    Class 3
  • Event Number
    Z-3084-2017
  • Event Initiated Date
    2017-06-26
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157665
  • 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 pcp (instead of tca) as one of the 10 drug analytes included in the kit. the pouch label, product insert, and the device itself are labeled correctly.
  • Action
    Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.

Device

Device Recall Alere iScreen Dx Urine Drug Screen Card
  • Model / Serial
    P/N IS10-DX; Lot No. U0731
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
  • Product Description
    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. || The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
  • Manufacturer
    Ameditech Inc

Manufacturer

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