Events

Retiro De Equipo (Recall) de Device Recall AIA Analyzer Pipette Tips

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 Tosoh Smd 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
    65576
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1830-2013
  • Fecha de inicio del evento
    2013-05-15
  • Fecha de publicación del evento
    2013-07-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119615
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Causa
    Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
  • Acción
    Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941. Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764. For questions regarding this recall call 614-317-1909.

Device

Device Recall AIA Analyzer Pipette Tips
  • Modelo / Serial
    The following lots numbers are affected by this recall:   060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.
  • Descripción del producto
    AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag || AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
  • Manufacturer
    Tosoh Smd Inc

Manufacturer

Tosoh Smd Inc
  • Dirección del fabricante
    Tosoh Smd Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    USFDA