Date Initiated by Firm |
August 24, 2016 |
Create Date |
November 02, 2016 |
Recall Status1 |
Terminated 3 on October 06, 2017 |
Recall Number |
Z-0329-2017 |
Recall Event ID |
75066 |
510(K)Number |
K042183
|
Product Classification |
Drink, glucose tolerance - Product Code MRV
|
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. |
Code Information |
Item Number: 10-O-050 Lot Number: 51426 Expiration Date: 05/2018 |
Recalling Firm/ Manufacturer |
Azer Scientific, Inc. 701 Hemlock Rd Morgantown PA 19543-9768
|
Manufacturer Reason for Recall |
Out of Specification Microbiological test results
|
FDA Determined Cause 2 |
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 in Commerce |
426 cases |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MRV and Original Applicant = EVER SCIENTIFIC
|