Events

Recall of Device Recall ToxCup Drug Screen Cup

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Branan Medical Corporation.

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
    67818
  • Event Risk Class
    Class 2
  • Event Number
    Z-1508-2014
  • Event Initiated Date
    2014-03-26
  • Event Date Posted
    2014-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126393
  • 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
    May be labeled with incorrect result interpretation graphics on the toxcup lid label.
  • Action
    The firm, Branan Medical Corp (BMC), sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 26, 2014 to all the customers who received the ToxCup Drug Screen Cup. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of product; quarantine all units of these product lots; destroy unused product(s) in compliance with your laboratory and state requirements; share this information with your staff and retain notification as part of your QS documentation; if distributed to your customers, provide a copy of this letter to them; complete and return the enclosed Customer Verification Form via Fax to: Branan Medical Corporation at 949-598-7167 or by e-mail at: branan.complaints@brananmedical.com within 10 days. Should you have any questions about the information contained in this notification, contact Branan Medical Corporation at (949) 598-7166 or email branan.complaints@brananmedical.com.

Device

Device Recall ToxCup Drug Screen Cup
  • Model / Serial
    Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of Canada.
  • Product Description
    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
  • Manufacturer
    Branan Medical Corporation

Manufacturer

Branan Medical Corporation
  • Manufacturer Address
    Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
  • Manufacturer Parent Company (2017)
    Branan Medical Corporation
  • Source
    USFDA