Recall of Device Recall BioRad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    The device was producing false negative results for cocaine tests.
  • Action
    Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed.


  • Model / Serial
    9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356,   94532016CE
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    60 consignees received the product in the US and 6 international consignees received the product. Distribution is limited to the following countries: Canada, France, UK, Germany and Italy.
  • Product Description
    Bio-Rad brand ''TOX/See Drug Screen Test''; || Catalog numbers: 1945182EX, 1945216, 194-5223
  • Manufacturer


  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source