Azer Scientific, Inc. recalls Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Or

Recalled November 9, 2016 · FDA recall Z-0330-2017 · Azer Scientific

Hazard

Out of Specification Microbiological test results · FDA Class II

Units

1,141 Cases

Sold at

Nationwide Distribution

Description

Out of Specification Microbiological test results

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.

Manufacturer(s)

Azer Scientific, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →