Events

Retiro De Equipo (Recall) de Device Recall Confirm Clearly Smart

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 Mizuho USA, 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
    36898
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0469-2007
  • Fecha de inicio del evento
    2006-11-17
  • Fecha de publicación del evento
    2007-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49537
  • 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
    Human chorionic gonadotropin (HCG) test-Pregnancy Test - Product Code LCX
  • Causa
    False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
  • Acción
    On November 14, 2006, Mizuho USA and SSL decided to cease further distribution of the product, and to contact SSL''s customers and ask them to return any unsold units. Mizuho USA informed SSL Americas by telephone. On November 21, 2006, SSL Americas sent Recall Notification Letters to each of its customers by US First Class, Certified, Return-receipt mail. The letter included a 'Fax Back' Notification to be use by the firm for recall effectiveness checks.

Device

Device Recall Confirm Clearly Smart
  • Modelo / Serial
    Confirm Clearly Starter Kits UPC Code 3-02340-30136-7 and Confirm Clearly Refills Kit UPC Code 3-02340-30138-1 (all lots including: Confirm Clearly Starter Kits Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611 Confirm Clearly Refills Kits Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610  Special Pack Deal (6 Starter Kits & 6 Refill Kits) Lot number; LH608
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA and Canada
  • Descripción del producto
    Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) || Note: || (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick || (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.
  • Manufacturer
    Mizuho USA, Inc.

Manufacturer

Mizuho USA, Inc.
  • Dirección del fabricante
    Mizuho USA, Inc., 12131 Community Rd, Poway CA 92064-8801
  • Source
    USFDA