Events

Recall of ArcPoint Labs 10 Panel Dip Screen (OXY)

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
    69333
  • Event Risk Class
    Class 2
  • Event Number
    Z-0073-2015
  • Event Date Posted
    2014-10-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130242
  • 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
    Ameditech is recalling the arcpoint labs dip drug screen dip card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
  • Action
    A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at amd.complaint@alere.com.

Device

ArcPoint Labs 10 Panel Dip Screen (OXY)
  • Model / Serial
    Lot No. 141001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in AL.
  • Product Description
    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. || The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
  • Manufacturer
    Ameditech Inc

Manufacturer

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