Azer Scientific Recalls Glucose Tolerance Beverage Due to Microbiological Test Failures
Azer Scientific, Inc. is recalling 426 cases of Orange Glucose Tolerance Beverage due to out-of-specification microbiological test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbiological contamination of a product intended for human consumption, which poses a risk of harm even without reported illnesses.
Plain-English summary
Azer Scientific, Inc. is recalling 426 cases of Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case. The product is an accessory used for In Vitro Diagnostic Oral Glucose Tolerance Tests (OGTT) to evaluate diabetes mellitus and related conditions. The specific item number is 10-O-050, lot number 51426, with an expiration date of 05/2018.
The recall was initiated because the product failed out-of-specification microbiological test results. The agency has classified this as a Class II recall. The product was distributed nationwide.
Consumers and healthcare facilities should stop using the affected product and contact Azer Scientific, Inc. for further instructions or a refund.
The recalled product
- 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…
- Manufacturer
- Azer Scientific, Inc.
- Affected units
- 426
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Azer Scientific, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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