Events

Retiro De Equipo (Recall) de VITROS Chemistry Products DT Calibrator Kit

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
    60799
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0917-2012
  • Fecha de inicio del evento
    2011-10-13
  • Fecha de publicación del evento
    2012-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106492
  • 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 (ocd) was notified by customers of negatively biased quality control results obtained while using vitros¿ chemistry products nbil dt slides, gen 72. ocd performed an internal investigation and confirmed that negatively biased nbil results could occur for quality control, proficiency and patient samples. as a result, vitros¿ chemistry products dt calibrator kit lots 37 &.
  • Acción
    Ortho Clinical Diagnostics (Johnson & Johnson Company) sent an Important Product Correction Notification letter dated October 13, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to recalibrate and instructing them to recalibrate VITROS¿ Chemistry Products NBIL DT Slides, GEN 72 with updated DT calibrator values for the NBIL assay provided on CDM 0164. J&J; Foreign affiliate consignees were notified by e-mail on October 13, 2011, informing them of the issue and of the availability of the updated CDM (0164). Consignees were instructed to complete and return the attached Confirmation of Receipt form upon receipt of the notification even if they do not use VITROS¿ NBIL Slides in their facility. If the affected product was distributed outside the consignees facility they were instructed to forward the notification letter to affected customers. For any questions regarding this recall call 1-800-421-3311.

Device

VITROS Chemistry Products DT Calibrator Kit
  • Modelo / Serial
    Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, and Venezuela
  • Descripción del producto
    VITROS¿ Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK || VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
  • 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