Recall of Device Recall AmediCheck Instant Test 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
    74600
  • Event Risk Class
    Class 3
  • Event Number
    Z-2311-2016
  • Event Initiated Date
    2016-07-05
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-10-04
  • Event Source
    USFDA
  • 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
    Branan medical is recalling the amedicheck instant test cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.
  • Action
    BMC sent an Urgent Medical Device Recall Notice letter on July 6, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the form even if they do not have affected product. The letter informs the customers that replacement product will be provided free of charge for any unused portion of the affected lot based on completion and return of the attached Customer Verification Form. Customers are instructed to return the completed Customer Verification within 10 business days of receipt by FAX at 949-598-7166, or by email at branan.complaints@brananmedical.com. Customers with any questions about the information contained in the notification are instructed to contact Branan Medical Corporation at 949-598-7166 or by e-mail at branan.complaints@brananmedical.com.

Device

  • Model / Serial
    T0858
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the states of: TN, NC, FL, and PA
  • Product Description
    AmediCheck Instant Test Cup, Part No. C-C0501A-3A || Product Usage: || The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
  • Manufacturer

Manufacturer

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