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Recall Observatory FDA recall evidence

Device 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.

Z-0330-2017

August 24, 2016

Class II

Product summary

Firm
Azer Scientific, Inc.
Event
Event 75066
Status
Terminated
Classification
Class II
Quantity
1,141 Cases
Official record key
device-enforcement:Z-0330-2017

Official wording

Reason: Out of Specification Microbiological test results

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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification