Events

Retiro De Equipo (Recall) de Device Recall AmediCheck Instant Test Cup

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Branan Medical Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74600
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2311-2016
  • Fecha de inicio del evento
    2016-07-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148018
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
  • Causa
    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.
  • Acción
    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

Device Recall AmediCheck Instant Test Cup
  • Modelo / Serial
    T0858
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the states of: TN, NC, FL, and PA
  • Descripción del producto
    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
    Branan Medical Corporation

Manufacturer

Branan Medical Corporation
  • Dirección del fabricante
    Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
  • Empresa matriz del fabricante (2017)
    Branan Medical Corporation
  • Source
    USFDA