Events

Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic HBsAg Controls

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
    74772
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0313-2017
  • Fecha de inicio del evento
    2016-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148410
  • 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
    Kit, serological, positive control - Product Code MJX
  • Causa
    The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. increased results may occur on both the negative and positive controls. the positive control, although showing elevated results, was still within acceptable performance.
  • Acción
    The firm, Ortho Clinical Diagnostics, distributed "Important Product Correction Notification" letters (Ref. CL2016-129) dated 6/22/2016 and Confirmation of Receipts to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only). Foreign affiliates were informed by email (on 22 June 2016) of the issue and instructed to notify their consignees of the issue and required actions. All customers who received the affected product were instructed to immediately discontinue using and discard the affected lots. Forward a copy of the notification if you have provided the affected lot(s) outside of your facility. Post a copy of the notification by each VITROS System that processes VITROS HBsAg Controls and Complete and return the Confirmation of Receipt-Response Required form via fax to: 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM no later 7/1/2016. (Note: If you DO NOT have an alternate lot, it is acceptable to continue using the affected lot(s) following these instructions: 1) Control results must be within acceptable limits on the day of reconstitution (Day 1). 2) Store open-reconstituted vials frozen for up to 4 weeks. The firm recommends that customers aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. 3) Upon receipt of your replacement order, discard all remaining inventory. Customers with questions please call the Ortho Technical Solutions Center at 1-800-421-3311.

Device

Device Recall VITROS Immunodiagnostic HBsAg Controls
  • Modelo / Serial
    Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 || For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
  • 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