Retiro De Equipo (Recall) de Device Recall Sickle Heme

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 MichClone Associates, 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
    Test, sickle cell - Product Code GHM
  • Causa
    Michclone associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. when the powders are opened, the pressure from within the vial releases a small amount of powder into the air. this powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. investigation f.
  • Acción
    Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: Questions and concerns should be addressed to Technical Support Department at 248-307-9494.


  • Modelo / Serial
    Lot# 1187, expiration date: 7/13  Catalog No.MCA-IOO, MHK 110A Powder Lot # 1171 (part of kit)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071. || For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
  • Manufacturer


  • Dirección del fabricante
    MichClone Associates, Inc., 680 Ajax Drive, Madison Heights MI 48071-2414
  • Source