Recall Z-2021-2014— DIABETIC SUPPLY OF SUNCOAST, INC.
Class I · Terminated
Class I FDA medical device recall by DIABETIC SUPPLY OF SUNCOAST, INC., initiated 2014-05-05, terminated 2017-06-13. It names one FDA 510(k) clearance: K120183. Product: 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.. Reason: "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips"..
- Recalling firm
- DIABETIC SUPPLY OF SUNCOAST, INC.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-05
- Terminated
- 2017-06-13
- Firm location
- Dorado, PR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
"Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".
Data sourced from openFDA. This site is unofficial and independent of the FDA.