Glucose Tolerance Beverage- Orange 50 gram Concentration — Class II medical device recall Z-0329-2017
Terminated recall by Azer Scientific, Inc., reported 2016-11-09, distributed nationwide. Out of Specification Microbiological test results
| Recall number | Z-0329-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Azer Scientific, Inc., Morgantown, PA, United States |
| Recall initiated | 2016-08-24 |
| Classified | 2016-11-02 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2017-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 426 cases |
| Reason classes | microbial contamination, specification failure |
| Lot numbers | 51426 |
| Model numbers | 10-O-050 |
| Expiration dates | 2018-05 |
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 for recall
Out of Specification Microbiological test results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0329-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.