Recall Z-0330-2017— Azer Scientific, Inc.

Name: FDA recall Z-0330-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-24

Class II · Terminated

Class II FDA medical device recall by Azer Scientific, Inc., initiated 2016-08-24, terminated 2017-10-06. It names one FDA 510(k) clearance: K042183. 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.. Reason: Out of Specification Microbiological test results.

Recalling firm: Azer Scientific, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Terminated: 2017-10-06
Firm location: Morgantown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K042183 — GLUCOSE TOLERANCE BEVERAGEEver Scientific·cleared 2004-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.