Events

Retiro De Equipo (Recall) de Device Recall Medplus ER Drug Screen Test

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 Applied Biotech Inc.

¿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
    35656
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1315-06
  • Fecha de inicio del evento
    2005-05-31
  • Fecha de publicación del evento
    2006-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46564
  • 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
    drug screen test - Product Code LCM
  • Causa
    The firm has discovered that a number of distributed devices of the medplus er drug screen test may be incorrectly assembled which may give incorrect results. the product is an in vitro test for rapid detection of various drugs such as amphetamines, barbiturates, phencyclidine, cocaine, methamphetamine, tricyclic antidepressants, morphine, tetrahydrocannabinol, & benzodiazepines in human urine.
  • Acción
    Recall notifications that describe the problem, dated May 31,2005, were sent via fax. Customers were instructed to block all stock of affected lots in their warehouse, contact their primary consignees and advise them to discontinue use immediately and dispose any unused materials. A faxback form was used to communicate to the recalling firm the quantity blocked and disposed of. Arrangements were made for providing replacement product.

Device

Device Recall Medplus ER Drug Screen Test
  • Modelo / Serial
    Lot Numbers Affected: 85699 and 85671
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide (distributors in KS and OR).
  • Descripción del producto
    Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box.
  • Manufacturer
    Applied Biotech Inc

Manufacturer

Applied Biotech Inc
  • Dirección del fabricante
    Applied Biotech Inc, 10237 Flanders Ct, San Diego CA 92121-2901
  • Source
    USFDA