Events

Retiro De Equipo (Recall) de Device Recall LeadCare Plus Blood Lead Analyzer

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 Magellan Diagnostics, 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
    79279
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1296-2018
  • Fecha de inicio del evento
    2018-01-09
  • Estado del evento
    Open, Classified
  • 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=161822
  • 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
    Lead, atomic absorption - Product Code DOF
  • Causa
    The incorrect placement of aa batteries into certain leadcare plus blood lead analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
  • Acción
    An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or LeadCareSupport@magellandx.com.

Device

Device Recall LeadCare Plus Blood Lead Analyzer
  • Modelo / Serial
    Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    LeadCare Plus Blood Lead Analyzer || Part Number: 82-0001 || Intended for the quantitative measurement of lead in a whole blood sample.
  • Manufacturer
    Magellan Diagnostics, Inc.

Manufacturer

Magellan Diagnostics, Inc.
  • Dirección del fabricante
    Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
  • Empresa matriz del fabricante (2017)
    Meridian Bioscience, Inc.
  • Source
    USFDA