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U.S. Department of Health and Human Services

Class 2 Device Recall Glucose Tolerance Drink

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  Class 2 Device Recall Glucose Tolerance Drink see related information
Date Initiated by Firm August 24, 2016
Create Date November 02, 2016
Recall Status1 Terminated 3 on October 06, 2017
Recall Number Z-0330-2017
Recall Event ID 75066
510(K)Number K042183  
Product Classification Drink, glucose tolerance - Product Code MRV
Product 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.
Code Information Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017 
Recalling Firm/
Manufacturer		 Azer Scientific, Inc.
701 Hemlock Rd
Morgantown PA 19543-9768
Manufacturer Reason
for Recall		 Out of Specification Microbiological test results
FDA Determined
Cause 2		 Unknown/Undetermined by firm
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.
Quantity in Commerce 1,141 Cases
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRV and Original Applicant = EVER SCIENTIFIC
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