Z-0330-2017 Class II Terminated

Recalled by Azer Scientific, Inc. — Morgantown, PA

Recall Details

Product Type
Devices
Report Date
November 9, 2016
Initiation Date
August 24, 2016
Termination Date
October 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,141 Cases

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.

Reason for Recall

Out of Specification Microbiological test results

Distribution Pattern

Nationwide Distribution

Code Information

Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017