Events

Retiro De Equipo (Recall) de Device Recall Dade(R) Actin(R) FSL Activated PTT 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 Siemens Healthcare Diagnostics, 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
    60982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1043-2012
  • Fecha de inicio del evento
    2011-12-19
  • Fecha de publicación del evento
    2012-02-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106986
  • 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
    Test, time, partial thromboplastin - Product Code GGW
  • Causa
    The listed lots of dade(r) actin(r) fsl reagent show an increase in heparin sensitivity over the shelf life which is demonstrated by testing with dade(r) citrol(r) heparin control, low and high.
  • Acción
    Siemens sent an Urgent Field Safety Notice letter dated December 2011 to all customers of the affected lots. The letter identified the product, description of problem, and actions to be taken by the user. Dade¿ Actin¿ FSL customers were instructed to exercise one of two options: 1) If customers would like to continue working with their Dade(R) Actin FSL reagent lot (if one of the impacted lots) they must verify on a regular basis (monthly) that their therapeutic range is still valid, e.g. by using a Heparin containing control. In the case that it is not valid, they are to adjust their existing therapeutic range or establish a new one. 2) If customers decide not to continue working with the Dade(R) Actin(R) reagent lot (if one of the impacted lots) they are to contact their Siemens representative at 1-800-242-3233, option 5, for a replacement lot. Once they have established a new normal, therapeutic, and quality control ranges, they are to discard the remainder of the old lot. Customers were advised to complete the response form included to confirm receipt of Safety Notice and fax back to (302) 631-8467. If you have any questions or concerns, please contact the Technical Solutions Center at 1-800-242-3233, option 1.

Device

Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent
  • Modelo / Serial
    Catalog number B4219-1J, lot numbers 537360, 537374 and 547301; catalog number B4219-1, lot numbers 537360A, 537366, 537374A, 547301A, and 547306; catalog number B4219-2J, lot numbers 534362 and 537365; and catalog number B4219-2, lot numbers 537362A and 537365A.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, Oman, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.
  • Descripción del producto
    Dade(R) Actin(R) FSL Activated PTT Reagent || Product Usage: || Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA