Events

Retiro De Equipo (Recall) de Device Recall Variant II Turbo

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 Bio-Rad Laboratories 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
    54684
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1898-2011
  • Fecha de inicio del evento
    2009-12-08
  • Fecha de publicación del evento
    2011-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89009
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Causa
    Wrong lot number was found on the hemoglobin cartridge insert . the insert did not match the lot number to the device cartridge or the device cartridge label or on the update kit cd.
  • Acción
    The firm, Bio-Rad, sent a "MEDICAL DEVICE CORRECTION" letter dated November 29, 2009 to all customers by Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 80080, please destroy the insert and use the new insert enclosed with the letter. 2) If their Lot No. LV90170B VARIANT II TURBO Hemoglobin A(10) Cartridge Set includes an insert referencing Lot No. 90170, they may continue using the insert. 3) Complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to: Bio-Rad CSD Regulatory Affairs Department at (510) 741-3954. If you have any questions, please call 510-724-7000 or contact your regional Bio-Rad office.

Device

Device Recall Variant II Turbo
  • Modelo / Serial
    Model Number(s): 270-2417 (Kit), with 270-2420 (Cartridge set) Code(s): LCP Listing Number(s): DO48707 for CDM 3.6T software Expiration date(s): Lot 70292242 EXP. Mar 31, 2010 and Lot 70292318 EXP. Jan. 31, 2010
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: CA, CT, GA, IL, IN, MA, ME, MS, NH, NV, OH, PA, TX, VA and WV; and countries including: France, Hong Kong, Italy, Korea and New Zealand.
  • Descripción del producto
    Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercules, CA 94547***" || Integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Dirección del fabricante
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA