Events

Retiro De Equipo (Recall) de Device Recall Glucose Tolerance Drink

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 Azer 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
    75066
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0330-2017
  • Fecha de inicio del evento
    2016-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149272
  • 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
    Drink, glucose tolerance - Product Code MRV
  • Causa
    Out of specification microbiological test results.
  • Acción
    Azer Scientific mailed an Urgent Medical Device Recall letter dated August 30, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to discontinue use of product and discard to avoid further distribution or use and to notify their customers/end users of the recall. Customers were asked to acknowledge receipt of the letter by completing the attached form and faxing it to (610) 901-3046. Customers with questions were instructed to call (610) 524-5810.

Device

Device Recall Glucose Tolerance Drink
  • Modelo / Serial
    Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Fruit Punch Glucose, 100 Gram Concentration, Liquid, || 4/Pack of 6 Bottles, 24/cs || Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
  • Manufacturer
    Azer Scientific, Inc.

Manufacturer

Azer Scientific, Inc.
  • Dirección del fabricante
    Azer Scientific, Inc., 701 Hemlock Rd, Morgantown PA 19543-9768
  • Empresa matriz del fabricante (2017)
    Azer Scientific Incorporated
  • Source
    USFDA