Events

Retiro De Equipo (Recall) de Device Recall Adenovirus (20/11 & 2/6)

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 Cell Marque Corporation.

¿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
    77209
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2199-2017
  • Fecha de inicio del evento
    2017-05-05
  • Fecha de publicación del evento
    2017-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155434
  • 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
    Antigens, cf (including cf control), adenovirus 1-33 - Product Code GOD
  • Causa
    Cell marque has determined the need to issue a product recall after identifying product intended to be sold outside the u.S. was not properly labeled as "for export only" as required by section 801 (e )(1) of the fd&c; act.
  • Acción
    Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.

Device

Device Recall Adenovirus (20/11 & 2/6)
  • Modelo / Serial
    0.5 mL - 1318203P , Expiry 2018-04; 7.0 mL - 1318204H 201, Expiry 8-04 11 and 1532111A, expiry 2018-10.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Descripción del producto
    Adenovirus (20/11 & 2/6); || 0.5 mL Catalog # 212M-15; || and 7.0 mL Catalog number 212M-18 || Microbiology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Dirección del fabricante
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Empresa matriz del fabricante (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA