Events

Retiro De Equipo (Recall) de Device Recall Kallestad (TM) HEp2

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.

¿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
    49083
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2429-2008
  • Fecha de inicio del evento
    2008-07-29
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72728
  • 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
    Antinuclear Antibody - Product Code DHN
  • Causa
    The homogeneous positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the qc report label included with each test kit.
  • Acción
    On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.

Device

Device Recall Kallestad (TM) HEp2
  • Modelo / Serial
    Lot # and exp: For number: 951562, exp 12/31/08; 953141, exp 1/31/09; 953242, exp 1/31/09; 953370, exp 1/31/09; 953402, exp 1/31/09; 953686, exp 1/31/09; 953687, exp 1/31/09; 953998, exp 1/31/09; 954045, exp 1/31/09; 954049, exp 1/31/09; 954226, exp 1/31/09; 954440, exp 1/31/09; 954441, exp 1/31/09; 954672, exp 3/31/09; 954711, exp 3/31/09; 954996, exp 3/31/09; 955096, exp 4/30/09; 955212, exp 4/30/09; 955314, exp 4/30/09; 955397, exp 4/30/09; and 955561, exp 4/30/09;
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.
  • Descripción del producto
    Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette".
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Dirección del fabricante
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA