FDA – StripSafely

August 01 2014

In: Blog
Posted By: StripSafely
Tags: FDA, recall, StripSafely, Test Strips
Comments: 2

Recall: Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips

Sorry we missed sharing this earlier: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm406243.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery Recall Class: Class I Date Recall Initiated: June 6, 2014 Products: Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – All Lots Distribution Dates: January, 2012 – June 6, 2014 Use: The Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips are used at home by people with diabetes to monitor their blood glucose

556, Thanks – Congratulations DOC!

StripSafely salutes the Diabetes Community’s strong and sustained level of comments to the FDA Glucose meter dockets. Accuracy Matters. Thanks! Here is the count at close: The personal use ‘over the counter’ docket 373* The professional ‘prescription’ use docket 183* 556 Comments! Ain’t America Great? * FDA notes: This count refers to the total comments received

Proposed New Meter Guidance from FDA: +/- 15% OTC. +/- 10% In Clinic

Proposed new guidance is out today from FDA on blood glucose meter systems (BGMS). There are two documents. One for patent users and one for use in clinical settings such as hospitals. I am still reading them but I thought other may wish to do so too. Much consideration of cleaning and disinfection of devices,

Posts Tagged / FDA