Retiro De Equipo (Recall) de Liquichek ToRCH Plus IgM Control

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Causa
    The liquichek" torch plus igm control - positive, contains detectable levels of hcv rna which originated from the non-specific human igm component used in the mouse monoclonal antibody conjugation process for this product.
  • Acción
    Bio-rad Laboratories initiated this recall on April 18, 2013, via telephone call and certified mailing to customers. The notification letter titled "Important Product Information Notice of Correction" was accompanied by a "Field Correction Notification Acknowledgement" form that notified customers of the product for recall (description and codes), issue (This product contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product), Customers were instructed to immediately discontinue use this lot of Liquichek ToRCH Plus IgM Control. Discard all remaining inventory of this lot of Liquichek ToRCH Plus IgM Control that you have at your location in accordance with the requirements of your local waste management authorities. Handle this product with the same precautions used with patient specimens. In accordance with good laboratory practice, all human source material should be considered potentially infectious. Have the appropriate laboratory personnel complete the acknowledgment form and email or fax it to us. It is very important to us to know that you have received the information provided in this Notice. Contact information (1-800-2-BIORAD)


  • Modelo / Serial
    Lot Number 18972, Catalog Number 229 and 229PX.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - Distributed in San Juan Puerto Rico and the states of NM, NY, MN, OR and WI., and the countries of Australia, Brazil, France, Italy, Korea, and New Zealand.
  • Descripción del producto
    Liquichek" ToRCH Plus IgM Control - Positive || Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM
  • Manufacturer


  • Dirección del fabricante
    Bio-rad Laboratories, Inc., 9500 Jeronimo Rd, Irvine CA 92618-2017
  • Empresa matriz del fabricante (2017)
  • Source