Z-2021-2014 Class I Terminated
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.