Events

Rappel de Device Recall Glucose Tolerance Drink

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Azer Scientific, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75066
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0330-2017
  • Date de mise en oeuvre de l'événement
    2016-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149272
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Drink, glucose tolerance - Product Code MRV
  • Cause
    Out of specification microbiological test results.
  • Action
    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
  • Modèle / numéro de série
    Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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.
  • Adresse du fabricant
    Azer Scientific, Inc., 701 Hemlock Rd, Morgantown PA 19543-9768
  • Société-mère du fabricant (2017)
    Azer Scientific Incorporated
  • Source
    USFDA