Events

Retiro De Equipo (Recall) de PLAC Test Reagent Kit, immunoturbidimetric method

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 DiaDexus, 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
    53856
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1750-2010
  • Fecha de inicio del evento
    2009-10-29
  • Fecha de publicación del evento
    2010-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86704
  • 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, system, immunoassay, lipoprotein-associated phospholipase a2 - Product Code NOE
  • Causa
    Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.
  • Acción
    Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.

Device

PLAC Test Reagent Kit, immunoturbidimetric method
  • Modelo / Serial
    Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to 123 consignees throughout the US.
  • Descripción del producto
    PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.
  • Manufacturer
    DiaDexus, Inc

Manufacturer

DiaDexus, Inc
  • Dirección del fabricante
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080
  • Empresa matriz del fabricante (2017)
    DiaDexus, Inc
  • Source
    USFDA