Events

Retiro De Equipo (Recall) de Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55

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 Siemens Healthcare Diagnostics, 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
    61610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1497-2012
  • Fecha de inicio del evento
    2011-06-16
  • Fecha de publicación del evento
    2012-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108535
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Causa
    Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
  • Acción
    Customer Notification letters were sent to all customers of the three MicroScan panels by traceable mail. The letter identified the affected product and asked customers to discard any remaining inventory in addition to contacting customer service for replacement product. The letter also recommended that customers consider the need to review previous test results, conduct patient follow-up, and or repeat tests as needed. Customers were to complete and return the customer reply card to confirm that they received and understood the recall communication.

Device

Device Recall MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55
  • Modelo / Serial
    lot code 2011-06-09.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Turkey, Poland, and Great Britain.
  • Descripción del producto
    MicroScan Dried Overnight Gram Negative Panels; || Panel type: Neg Urine Combo 55; Catalog Number B1017-409. || Siemens Healthcare Diagnostics, || West Sacramento, CA.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA