Events

Retiro De Equipo (Recall) de IsSyphilis TREPCHEK Test Kit.

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 Diamedix 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
    30165
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0325-05
  • Fecha de inicio del evento
    2003-09-11
  • Fecha de publicación del evento
    2004-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35294
  • 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 Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
  • Causa
    Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
  • Acción
    Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.

Device

IsSyphilis TREPCHEK Test Kit.
  • Modelo / Serial
    The kit lot number is 42003. The conjugate lot number is 42023.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to 54 laboratory accounts throughout the US.
  • Descripción del producto
    The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. || The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Dirección del fabricante
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA