Events

Recall of DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Drug Free Enterprises 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
    27817
  • Event Risk Class
    Class 3
  • Event Number
    Z-0239-04
  • Event Initiated Date
    2003-03-20
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30567
  • 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, Cocaine And Cocaine Metabolites - Product Code DIO
  • Reason
    Lacks professional use labeling and firm name and address.
  • Action
    Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.

Device

DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

Manufacturer

Drug Free Enterprises Inc
  • Manufacturer Address
    Drug Free Enterprises Inc, 5302 Derry Ave Ste A, Agoura Hills CA 91301-6022
  • Source
    USFDA