Z-2021-2014 Class I Terminated

Recalled by DIABETIC SUPPLY OF SUNCOAST, INC. — Dorado, PR

Recall Details

Product Type
Devices
Report Date
July 30, 2014
Initiation Date
May 5, 2014
Termination Date
June 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,852,800 cases (50 strips ea)

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".

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam

Code Information

All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.