Events

Retiro De Equipo (Recall) de Liquid Stable 2Part Homocysteine Reagent

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 Medtest Holdings, 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
    74234
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2063-2016
  • Fecha de inicio del evento
    2015-04-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146910
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Causa
    Deterioration in performance of the liquid stable (ls) 2-part homocysteine reagent resulting in under recovery. the manufacturer has indicated that the homocysteine reagent lot listed above shows deterioration in assay performance manifesting itself by under recovery of homocysteine in controls and patient samples. the cause of this deterioration has been attributed to a loss of reductant activity in reagent 1. testing performed indicated that the affected lot is at the limit of acceptable clinical performance. this observation was consistent across the reportable range of the assay. for this reason, do not continue to use affected reagent lot. test data generated to date will be acceptable where validity control specifications have been met.
  • Acción
    On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

Liquid Stable 2Part Homocysteine Reagent
  • Modelo / Serial
    Model: H7575-57 Lot: 416703 Expiration date: 2016-01
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    MI, MN, NJ, IL, NY. US Only.
  • Descripción del producto
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

Medtest Holdings, Inc.
  • Dirección del fabricante
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Empresa matriz del fabricante (2017)
    Medtest Holdings Inc
  • Source
    USFDA