Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products Specialty Diluent

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 Ortho-Clinical Diagnostics.

¿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
    67883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1519-2014
  • Fecha de inicio del evento
    2014-03-26
  • Fecha de publicación del evento
    2014-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126555
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Ortho clinical diagnostics (ocd) confirmed the potential for lower than expected c-reactive protein (crp) results only to be generated when using vitros chemistry products specialty diluent (lot f3168) or vitros chemistry products fs diluent pack 3 (lot 01-3266). the vitros instructions for use states that if the if a c-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with vitros specialty diluent or a patient sample containing a low concentration of crp. an initial threefold dilution is recommended. internal testing determined that results using vitros crp slides have the potential for approximately 51% bias using a 3x dilution factor.
  • Acción
    On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J; Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.

Device

Device Recall VITROS Chemistry Products Specialty Diluent
  • Modelo / Serial
    Lot F3168 (exp. 30 Sep 2014)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA