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Recall Observatory FDA recall evidence

Device 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.

Z-2021-2014

May 05, 2014

Class I

Product summary

Firm
DIABETIC SUPPLY OF SUNCOAST, INC.
Event
Event 68196
Status
Terminated
Classification
Class I
Quantity
1,852,800 cases (50 strips ea)
Official record key
device-enforcement:Z-2021-2014

Official wording

Reason: "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".