Events

Retiro De Equipo (Recall) de Device Recall VITROS

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
    61175
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1277-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-22
  • 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=107462
  • 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, multi-analyte mixture - Product Code JIX
  • Causa
    Ortho clinical diagnostics received complaints of lower than expected results (< 6 u/l) for samples that were known to be outside of the measuring (reportable) range (> 1000 u/l) when using calibration diskette/assay data diskette data release version (drv) 5653 through 5666 and vitros¿ chemistry products alt slides, generation (gen) 26 (product code 1655281).
  • Acción
    Ortho Clinical Diagnostic sent a Important Product Correction letter dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to: Install Calibration Diskette/Assay Data Diskette DRV 5667 on your VITROS System. Following a successful recalibration, you may resume using VITROS¿ ALT Slides, GEN 26 remaining in your inventory. To please complete and return the Confirmation of Receipt form upon receipt of this notification. Please return this form no later than February 17, 2012. Post this notification by each VITROS¿ System in your facility that utilizes the VITROS¿ ALT Slides, or with the VITROS¿ user documentation. Forward this notification if you have distributed this product outside of your facility. We apologize for the inconvenience this may have caused your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS
  • Modelo / Serial
    Calibration Diskette (Product Code 8716607) and the Assay Data Diskette (Product Code 6801876), Data Release Version (DRV) 5653 through 5666 used in conjuction with of VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems --- Universal Calibration Diskette --- [REF] 871 6607 --- Ortho-Clinical Diagnostics" || For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of AcP, ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.
  • 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