Events

Recall of Device Recall Glucose Tolerance Drink

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Azer Scientific, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75066
  • Event Risk Class
    Class 2
  • Event Number
    Z-0330-2017
  • Event Initiated Date
    2016-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149272
  • Notes / Alerts
    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.
  • Extra notes in the data
    Drink, glucose tolerance - Product Code MRV
  • Reason
    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
  • Model / Serial
    Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer Address
    Azer Scientific, Inc., 701 Hemlock Rd, Morgantown PA 19543-9768
  • Manufacturer Parent Company (2017)
    Azer Scientific Incorporated
  • Source
    USFDA