Events

Retiro De Equipo (Recall) de VITROS Clinical Chemistry Products Homocysteine (HCY) 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 Ortho-Clinical Diagnostics.

¿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
    64874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1556-2013
  • Fecha de inicio del evento
    2013-04-01
  • Fecha de publicación del evento
    2013-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117225
  • 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
    The firm is recalling the specific lot due to lower than expected results.
  • Acción
    Ortho Clinical Diagnostics sent an "Important Product Correction Notification" letter dated April 1, 2013 to all affected customers. Ortho Clinical Diagnostics recommends that their customers immediately discontinue using and discard all VITROS HCY Reagent remaining in your inventory for the affected lot. They have requested that their customers complete and return the attached Confirmation of Receipt form no later than April 12, 2013. Ortho Clinical Diagnostics requested that these notifications be forwarded to all laboratories and posted beside each VITROS System that utilizes VITROS HCY Reagent within their customers facilities. To place a product order for an alternate lot, please contact Ortho Clinical Diagnostics customer service representatives at 1-800-828-6316. The VITROS Chemistry Products HCY Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure total homocysteine concentration in human serum and plasma.

Device

VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent
  • Modelo / Serial
    Lot # 1529-17-2636, expiration date 12 June 2013
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
  • Descripción del producto
    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. || Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA