Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products CRBM Slides

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
    67788
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1470-2014
  • Fecha de inicio del evento
    2014-03-05
  • Fecha de publicación del evento
    2014-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126327
  • 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
    Enzyme immunoassay, carbamazepine - Product Code KLT
  • Causa
    The firm identified a potential for biased carbamazepine (crbm) results to be generated when using vitros crbm slides, lot 3920-0080-8403.
  • Acción
    The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remaining inventory of VITROS CRBM Slides, Lot 3920-0800-8403; review previously reported results using this lot; discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician; complete the attached Confirmation of Receipt form no later than March 14, 2014; and forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS Chemistry Products CRBM Slides
  • Modelo / Serial
    Lot 3920-0080-8403, expiry date 15-JUNE-2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: IN, MD, and TN.
  • Descripción del producto
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • 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