Events

Retiro De Equipo (Recall) de Device Recall The LeadCare Ultra Blood Lead Testing System

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
    76991
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1925-2017
  • Fecha de inicio del evento
    2014-11-29
  • Fecha de publicación del evento
    2017-05-18
  • Estado del evento
    Completed
  • 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=154782
  • 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
    Leadcare plus and leadcare ultra blood lead testing systems may generate falsely low lead concentrations in some blood samples. the issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the becton dickinson edta vacutainer tubes, a collection device used with the testing system.
  • Acción
    Magellan issued a follow-on Recall notification related to the FDA Safety Notification dated May 17, 2017. This current recall follows FDAs recommendation to remove venous blood samples as an allowable sample type from all LeadCare products. This recall will supersede and replace the prior Recall notifications. Notifications issued by : UPS Letter (US), Registered Letter, E-mail, or Phone calls form May 23-May 25. Questions: Reba Daoust, Director of QA/RA 978-248-4811 or rdaoust@magellandx.com Refer to Firm's website: http://www.leadcare2.com/getmedia/2fd8a90f-5c64-4058-b6ab-5db13512f0fe/Letter-to-our-customers-5-17-17.pdf.aspx. The notification of May 2017 supercedes the firms previous communications:. Magellan Diagnostics, notified customers by letter dated Nov 29, 2014 and provided with the problem, mitigation action( customers have been advised to implement a minimum 24-hour incubation of the blood-treatment reagent mixture prior to analysis) . Customers were instructed to return a completed FaxBack form via fax to 978-600-1480. A revised letter issued May 1, 2017 recommending that customers make the following workflow changes: 1. Discontinue collecting blood samples for lead testing in Becton Dickinson (BD) EDTA Vacutainer¿ tubes: Lavender and Tan tops. 2. Discontinue the 24 hour incubation for sample preparation. On 5/17/17 FDA issued News Release - FDA warns Americans about risk of inaccurate results from certain lead tests- manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults. Blood drawn from a vein may provide results that are lower than the actual level in the blood. FDA is warning laboratories not to use Magellan Diagnostic lead tests wit blood drawn from the vein. At this time all Leadcare systems can be used with blood drawn from a finger or heel stick. Based on FDA/s warning the firm issued notification letter to users on 5/xx/17.

Device

Device Recall The LeadCare Ultra Blood Lead Testing System

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