Events

Retiro De Equipo (Recall) de Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagent

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 Beckman Coulter 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
    56247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2653-2010
  • Fecha de inicio del evento
    2010-06-28
  • Fecha de publicación del evento
    2010-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93055
  • 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
    Immunoglobulin A (Ig-A) Reagent - Product Code DEW
  • Causa
    The recall was initiated after beckman coulter inc. confirmed reports of high recovery of immunoglobulin a (iga) in proficiency surveys or patient samples using synchron ig-a reagent lots m812164 or m902345. using these reagent lots, some samples deficient in iga have yielded results in the normal range. other samples with normal levels of iga have yielded falsely high results.
  • Acción
    A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent. Customers were instructed to: (1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options. (2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. Customers were also instructed to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

Device

Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagent
  • Modelo / Serial
    Lot Numbers: M812164, M902345
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide & Canada
  • Descripción del producto
    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA