Events

Retiro De Equipo (Recall) de ELECSYS CrossLaps/Serum Immunoassay

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 Roche Diagnostics Operations, 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
    65163
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1727-2013
  • Fecha de inicio del evento
    2013-04-25
  • Fecha de publicación del evento
    2013-07-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118059
  • 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
    Column chromatography & color development, hydroxyproline - Product Code JMM
  • Causa
    Roche diagnostics internal investigations in r&d; have shown that the claims for biotin interference and the sample stability given in the elecsys ¿-crosslaps (¿-cl) assay package insert version 5, could not be reproduced. the ¿-crosslaps test results contribute to the monitoring of antiresorptive therapy. false low or false normal results may lead to delayed diagnosis and treatment of osteoporosi.
  • Acción
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" (UMDC)letter dated May 2, 2013, to its consignees/customers via UPS Ground. The letter describes the product, problem and actions to be taken. The consignees/customers were instructed to apply the correct sample storage conditions as stated in the UMDC and to inform all relevant parties about the correct biotin interference claim. The consignees/customers were instructed to keep the UMDC on file for reference until the revised package insert is available. The consignees/customers were asked to complete and return a form via fax (1-888-943-4205). Consignees/customers were instructed to call Roche Diagnostics Technical Support, 24 hours a day, seven days a week, at 1-800-428-2336 if they had any questions about the recall. Non-responding accounts are monitored on an ongoing basis.

Device

ELECSYS CrossLaps/Serum Immunoassay
  • Modelo / Serial
    All lot numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.
  • Descripción del producto
    B-CrossLaps/serum (B-CTx in serum) || REF 11972308 160 || 100 tests || Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA