Events

Retiro De Equipo (Recall) de Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution

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 Tosoh Bioscience 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
    79708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1812-2018
  • Fecha de inicio del evento
    2018-03-05
  • 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=163126
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    The assay can potentially generate erroneously elevated or erroneously decreased hba1c patient results.
  • Acción
    On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.

Device

Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Descripción del producto
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 || The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Dirección del fabricante
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    USFDA