Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products CDM PROM

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
    67509
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1490-2014
  • Fecha de inicio del evento
    2014-01-29
  • Fecha de publicación del evento
    2014-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125634
  • 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
    Enzymatic method, creatinine - Product Code JFY
  • Causa
    Customers were unable to calibrate, or use previously calibrated, vitros dt crsc slides (ref/product code 6802721), gen 82, on the vitros dt ii system, when using calibration data module (cdm) rev. 168 (ref/product code 199 9077), as cdm 168 does not contain calibration parameters for dt crsc.
  • Acción
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification Letters dated January 29, 2014, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue. Customers were advised to Inspect their inventory to determine if they had VITROS CRSC DT Slides, GEN 82. - To use their current inventory of GEN 82 until the replacement order arrives providing that they have CDM PROM 0167 installed on their system and calibrate using VITROS DT Calibrator Kit, Lot 42. - If product replacement is required, discard their remaining inventory of VITROS CRSC DT Slides, GEN 82 upon receipt of their replacement order. - Complete and return the Confirmation of Receipt Form by February 7, 2014, by fax to 1-888-557-3759 or 1-585-453-04110, or email to: ConfirmationAdmin@its.jnj.com. Indicate on the form if they have any inventory of the affected lot that will require replacement. - Forward this information if they have distributed this product outside of your facility. Distributors were also instructed to identify all customers and any other branches who were shipped VITROS CRSC DT Slides, GEN 82 from their facility and send a copy of the Urgent Product Correction Notification Letter to inform them of the issue. Foreign affiliates were informed by e-mail on January 22, 2014, of the issue and instructed to notify their consignees of the issue and required actions.

Device

Device Recall VITROS Chemistry Products CDM PROM
  • Modelo / Serial
    Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and || VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
  • 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