Retiro De Equipo (Recall) de Sysmex StromatolyserIM (SIM220A)

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 Sysmex America, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Products, red-cell lysing products - Product Code GGK
  • Causa
    The affected lots of stromatolyser-im lysing reagent were found to be contaminated with pseudomonas bacteria, which resulted in rising imi channel background counts, increased false "platelet clump" flags and a strong sulfur-like odor when used on the xe-2100, xe-2100l and xe-5000 analyzers.
  • Acción
    Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.


  • Modelo / Serial
    Catalog number SIM-220A, lot numbers Y0053, Y0054, Y0055
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution--USA (nationwide and Puerto Rico) and the countries of Canada, Colombia, Ecuador, Mexico, Netherland Antilles and Peru.
  • Descripción del producto
    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
  • Manufacturer


  • Dirección del fabricante
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Empresa matriz del fabricante (2017)
  • Source