Recall Z-2021-2014 ยท CGA Glucose Oxidase, Glucose
DIABETIC SUPPLY OF SUNCOAST, INC.
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.
| Date | Jul 22, 2014 (initiated May 5, 2014) |
| Status | Terminated |
| Reason | "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips". |
| Root cause | Labeling False and Misleading |
| Action | Diabetic Supply of Suncoast, Inc. sent an Urgent Voluntary Medical Device Recall letter dated June 6, 2014, to all affected consignees. The firm is asking the distributors to examine their inventory immediately and quarantine any product subject to recall. In addition, if they may have further distributed this product, to please identify their customers and notify them at once of this product recall. Customers who have the BMB-BA006A Advocate Redi-Code+ test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information to determine if the products are being used in th |
| Quantity | 1,852,800 cases (50 strips ea) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120183 | ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM Broadmaster Biotech Corperation, May 11, 2012 |