Events

Retiro De Equipo (Recall) de Clinical Chemistry Iron/Magnesium Calibrator

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 Abbott Laboratories Inc..

¿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
    48172
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0950-2009
  • Fecha de inicio del evento
    2008-04-24
  • Fecha de publicación del evento
    2009-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70929
  • 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
    Multi-Analyte Mixture Calibrator - Product Code JIX
  • Causa
    An incorrect magnesium calibrator 2 value (cal 2) was provided for clinical chemistry iron/magnesium calibrator lot number 54187m200. use of the incorrect magnesium cal 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8meq/l (1.0 mg/dl or 0.4 mmol/l).
  • Acción
    On April 24, 2008, a Product Correction letter with attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. Customer reply form were included in all US customers letter. The letter instructed customers to: 1. Identify the lot number of Clinical Chemistry Iron/Magnesium Calibrator currently used in your laboratory 2. If you have lot number 54187M200, cross out the incorrect Magnesium CAL 2 value in the value sheet, commodity 30-3535/R1, June 2005. Place a copy of this letter in all calibrator kits with this lot number. 3. Enter the revised Magnesium CAL 2 value provided in this letter in your system. NOTE: Ensure that the value used corresponds to the units of concentration used in your laboratory. *ARCHITECT cSystems - Refer to Enter a calibrator concentration (cSystem) in Section 2, Installation procedures and special requirements of the ARCHITECT System Operations Manual. *AEROSET - Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. 4. Calibrate the Magnesium assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory. Customers were also instructed to please retain this communication for future reference and if they have forwarded any Clinical Chemistry Iron/Magnesium Calibrator to another laboratory, please provide a copy of this letter to them. An 800 number was provided in the recall letter for any questions the affected customers or any of the health care providers they serve may have.

Device

Clinical Chemistry Iron/Magnesium Calibrator
  • Modelo / Serial
    Lot Number: 54187M200
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI, and countries of Mexico, Chile, Puerto Rico, Canada, Thailand, Curacao, Guatemala, Argentina, Dominican Republic, Germany, New Zealand, Jamaica, Ecuador, Brazil, El Salvador, Hong Kong, and Bermuda.
  • Descripción del producto
    Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200 || For use in the calibration of the Iron and Magnesium assays.
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Dirección del fabricante
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA