Retiro De Equipo (Recall) de Device Recall DSL108000 Active IPTH ELISA

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 Beckman Coulter 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Radioimmunoassay, parathyroid hormone - Product Code CEW
  • Causa
    The recall was initiated after beckman coulter confirmed that the stated stability of the dsl-10-8000 i-pth elisa assay may not be achieved for lot numbers: 891198, 990980 and 991448. the kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. therefore the affected i-pth elisa kit lots may produce falsely elevated patient r.
  • Acción
    Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit; (3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped. Alternate lots will be provided for current and future replenishment orders or requests. in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For questions regarding this recall contact (800) 231-7970.


  • Modelo / Serial
    Lot Numbers: 891198, 990980, 991448
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
  • Descripción del producto
    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
  • Manufacturer


  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
  • Source