Events

Retiro De Equipo (Recall) de Device Recall PROT 1 CON M

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
    77381
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0175-2018
  • Fecha de inicio del evento
    2017-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155945
  • 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
    Immunochemical, ceruloplasmin - Product Code CHN
  • Causa
    Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dl [0.2 g/l]. prot1 cal and corresponding prot1 con l, m, and h are inaccurately assigned for ceruloplasmin (cer).
  • Acción
    Siemens issued an Urgent Medical Device Correction (UMDC) letter (PP-17-012.A.US, dated May 23, 2017) to US customers on May 23, 2017 and an Urgent Field Safety Notice (UFSN) to customers Outside the US in May 2017. Customers were instructed in the letter to use re-assigned CER values for the lots indicated of PROT1 CAL and PROT1 CON L, M, and H. In the US, the method of distribution is FEDEX and outside the US, the distribution is determined at the country level. Customers were requested to complete Effectiveness Check questionnaire attached to the UMDC/UFSN and return to Siemens within 30 days.

Device

Device Recall PROT 1 CON M
  • Modelo / Serial
    Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) ---  Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131),  6BQM01A (008427680063406BQM01A20170617),  6BQM01B (008427680063406BQM01B20170617),  6BQM01C (008427680063406BQM01C20170617),  6BQM01D( 008427680063406BQM01D20170617),  6BQM01E (008427680063406BQM01E20170617),  6FQM01(008427680063406FQM0120171103),  6FQM01A (008427680063406FQM01A20171103).
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
  • Descripción del producto
    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA