Events

Retiro De Equipo (Recall) de Device Recall Presage ST2 Assay

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 Critical 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
    62281
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2012-2012
  • Fecha de inicio del evento
    2012-02-28
  • Fecha de publicación del evento
    2012-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110097
  • 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
    ST2 assay - Product Code OYG
  • Causa
    The recall was initiated because critical diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the presage st2 assay kits.
  • Acción
    Critical Diagnostics sent a Medical Device Recall letter dated March 5, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were instructed to please use Federal Express (FedEx) to return the kits, and charge to account: 305599069 Replacement kits will be sent to you. Customers with questions about this notice were instructed to contact Critical Diagnostics' customer support at (877) 700-1250 ext 3.

Device

Device Recall Presage ST2 Assay
  • Modelo / Serial
    BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
  • Descripción del producto
    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. || The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
  • Manufacturer
    Critical Diagnostics

Manufacturer

Critical Diagnostics
  • Dirección del fabricante
    Critical Diagnostics, 3030 Bunker Hill St Ste 115a, San Diego CA 92109-5754
  • Empresa matriz del fabricante (2017)
    Critical Diagnostics Inc.
  • Source
    USFDA