Events

Retiro De Equipo (Recall) de Device Recall N Latex HCY

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
    76251
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1227-2017
  • Fecha de inicio del evento
    2017-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152588
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Causa
    The firm confirmed a reduced once-opened and on-board stability for n latex homocysteine (hcy) opax03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. the stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
  • Acción
    URGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days; Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall N Latex HCY
  • Modelo / Serial
    Lot 802907632, Exp. 2017-02-13
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.
  • Descripción del producto
    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD || Product Usage: || In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA