Events

Retiro De Equipo (Recall) de Device Recall Pointe Scientific Glucose Oxidase Reagent

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 Pointe Scientific, 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
    50131
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1091-2009
  • Fecha de inicio del evento
    2008-11-03
  • Fecha de publicación del evento
    2009-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74794
  • 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
    Glucose Oxidase - Product Code CGA
  • Causa
    The product is unable to maintain the specification for linearity through the shelf life of the product.
  • Acción
    Consignees were notified via an Urgent: Medical Device Recall letter dated 11/3/08 that all test results obtained with these lots are questionable and that attending physicians should be informed to determine whether additional testing is required. Also, consignees should examine their inventories for any of the lot numbers listed and dispose of them. If the product has been further distributed, identify customers and notify them of the product recall by including a copy of the recall letter. The Recall Return Response Form should be completed and returned and upon receipt Pointe Scientific will replace any disposed of reagent. Questions should be directed to the Technical Support Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific Glucose Oxidase Reagent
  • Modelo / Serial
    All lots beginning in 722601, Exp. 08/09. (Lots 722601, 722601-009, 722601-017, 722601-035, 722601-057, 722601-072, 722601-081, 722601-084, 722601-085, 722601-092, 722601-093, 722601-094, 722601-134, 722601-136, 722601-168, 722601-185, 722601-232, 722601-233, 722601-254, 722601-255, 722601-318, 722601-337, and 722601-361.)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela.
  • Descripción del producto
    Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. || For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

Pointe Scientific, Inc.
  • Dirección del fabricante
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
  • Empresa matriz del fabricante (2017)
    MedTest Holdings
  • Source
    USFDA