Azer Scientific, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0330-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 24, 2016

Date Posted: November 9, 2016

Recall Number: Z-0330-2017

Event ID: 75066

Reason for Recall:

Out of Specification Microbiological test results

Status: Terminated

Product Quantity: 1,141 Cases

Code Information:

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

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated