The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0330-2017·Announced 2016-11-09

Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures

Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, 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 out-of-specification microbiological test results, which presents a risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Azer Scientific, Inc. is recalling Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles. The product is an accessory used for In Vitro Diagnostic Oral Glucose Tolerance Tests (OGTT) to evaluate diabetes mellitus and related conditions. The recall involves 1,141 cases distributed nationwide.

The recall was initiated because the product failed out-of-specification microbiological test results. The specific affected lot is identified by Item Number 10-FP-100, Lot Number 49936, and an expiration date of 11/2017.

Consumers and healthcare facilities should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to Azer Scientific, Inc. according to the company's instructions.

The recalled product

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…
Manufacturer
Azer Scientific, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
1,141

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-FP-100 Lot Number: 49936 Expiration Date: 11/2017

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 →

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