Events

Retiro De Equipo (Recall) de Leica Microsystems, Inc.

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 Leica Microsystems, 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
    72288
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0341-2016
  • Fecha de inicio del evento
    2015-09-03
  • Fecha de publicación del evento
    2015-11-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140480
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Causa
    These lot numbers are not stable up to the expiry date on the product labeling.
  • Acción
    Leica sent a MEDICAL DEVICE RECALL NOTIFICATION letter dated September 3, 2015 via mail to all of the consignees. The letter identified the affected, product, problem and actions to be taken. Customers are instructed to discontinue use of the reagent lots listed in the recall notification. It is requested that customers appropriately destroy any unused or partially used affected lots of the reagent, and indicate on the attached Medical Device Recall Notification Acknowledgement Form that this action has been undertaken. Customers were asked to confirm receipt of the notice as soon as possible by signing and dating the attached Medical Device Recall Notification Acknowledgement Form and fax it back to1-847-236-3747, to receive your alternative replacement for applicable orders. For questions contact your local Leica representative.

Device

Leica Microsystems, Inc.
  • Modelo / Serial
    CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016.   CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.
  • Descripción del producto
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Dirección del fabricante
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA