Class II — Azer Scientific, Inc.
| Recalling firm | Azer Scientific, LLC |
|---|---|
| Registered facility | AZER SCIENTIFIC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Out of Specification Microbiological test results |
| 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 in… |
| Quantity | 1,141 Cases |
| Distribution | Nationwide Distribution |
| Initiated | 2016-08-24 |
| Classified | 2016-11-02 |
| Terminated | 2017-10-06 |
| Recall number | Z-0330-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Azer Scientific, Inc. (Z-0330-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75066/
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