FDA Device recall Z-0329-2017
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Gluc…
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Gluc… by Azer Scientific, citing out of Specification Microbiological test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0329-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-24 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Azer Scientific |
| Distribution | US |
Product
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case 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
Identifiers
| code_info | Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0329-2017%22
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