Events

Recall of Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Express Diagnostics Int'l., 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
    70008
  • Event Risk Class
    Class 2
  • Event Number
    Z-1033-2015
  • Event Initiated Date
    2014-11-21
  • Event Date Posted
    2015-01-30
  • 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=132104
  • 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
    Test system, for drugs of abuse - Product Code MGX
  • Reason
    This recall has been initiated due to potential false positives results when using the test to screen for ketamine. use of this product may give incorrect screening results.
  • Action
    Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.

Device

Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test
  • Model / Serial
    PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
  • Product Description
    DrugCheck Ketamine Dip Test || 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. || This assay provides only a preliminary analytical test result.
  • Manufacturer
    Express Diagnostics Int'l., Inc.

Manufacturer

Express Diagnostics Int'l., Inc.
  • Manufacturer Address
    Express Diagnostics Int'l., Inc., 1550 Industrial Dr, Blue Earth MN 56013-1100
  • Manufacturer Parent Company (2017)
    Express Diagnostics Intl Inc.
  • Source
    USFDA