Events

Retiro De Equipo (Recall) de Device Recall SickleScan

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
    Recall
  • ID del evento
    61384
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1503-2012
  • Fecha de inicio del evento
    2012-02-23
  • Fecha de publicación del evento
    2012-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108090
  • 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
    Two complaints concerning the powder vial included in the 100 test kit has been 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 found no affect on the perf.
  • 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: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.

Device

Device Recall SickleScan
  • Modelo / Serial
    Lot# 1187, expiration date: 7/13  Catalog No.13-2101, Powder Lot # 1171 (part of kit)
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. || For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
  • Manufacturer
    MichClone Associates, Inc.

Manufacturer

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