Recall of 1 Step 12 Panel Cup

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • 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, benzodiazipine - Product Code JXM
  • Reason
    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
  • Action
    Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to For questions regarding this recall call 858-535-1968.


  • Model / Serial
    144408 150675
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Product Description
    1 Step 12 Panel Cup, Item No. NBCA-12M-W || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
  • Manufacturer


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