Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products FS Calibrator 1

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
    76200
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1181-2017
  • Fecha de inicio del evento
    2017-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152503
  • 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
    Calibrator, secondary - Product Code JIT
  • Causa
    The company received a customer complaint for the inability to calibrate vitros chemistry products dldl reagent when using vitros fs calibrator 1, lot 91461 and add (drv 5908). assay data disk (add) drv versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
  • Acción
    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2017-002) and ADD DRV 5911dated January 5, 2017, to all affected customers. The letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to install Assay Data Diskette, DRV 5911 or above on their VITROS System. Foreign affiliates were informed by e-mail on January 5, 2017, of the issue and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Ortho Care Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products FS Calibrator 1
  • Modelo / Serial
    Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most || current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator || 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. || VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA