FDA Medical Device Recalls (openFDA)
Azer Scientific, Inc.: 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.
- Recall number
- Z-0330-2017
- Recalling firm
- Azer Scientific, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-08-24
- Posted
- not on file
- Terminated
- 2017-10-06
- Reason
- Out of Specification Microbiological test results
- Root cause
- Unknown/Undetermined by firm
- Action
- Azer Scientific mailed an Urgent Medical Device Recall letter dated August 30, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to discontinue use of product and discard to avoid further distribution or use and to notify their customers/end users of the recall. Customers were asked to acknowledge receipt of the letter by completing the attached form and faxing it to (610) 901-3046. Customers with questions were instructed to call (610) 524-5810.
- Quantity
- 1,141 Cases
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Item Number: 10-FP-100 Lot Number: 49936 Expiration Date: 11/2017
- 510(k) numbers
- ["K042183"]
- PMA numbers
- not on file
- Product code
- MRV
- Firm FEI
- 3009963993
- Firm city
- Morgantown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28