Events

Retiro De Equipo (Recall) de Device Recall Mycoplasma IgM ELISA 96 Well K

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 Calbiotech 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
    50691
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0998-2010
  • Fecha de inicio del evento
    2008-08-27
  • Fecha de publicación del evento
    2010-03-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76378
  • 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
    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. - Product Code LJZ
  • Causa
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Acción
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.

Device

Device Recall Mycoplasma IgM ELISA 96 Well K
  • Modelo / Serial
    Lot Number: MPM2400, MPM2443 and MPM2544
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    FL, and VA
  • Descripción del producto
    Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M || The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
  • Manufacturer
    Calbiotech Inc

Manufacturer

Calbiotech Inc
  • Dirección del fabricante
    Calbiotech Inc, 10461 Austin Dr Ste G, Spring Valley CA 91978-1524
  • Source
    USFDA