The Recall Desk
SevereFDA (Devices)·Z-2021-2014·Announced 2014-07-30

Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing

Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum severity score of 4 (Severe) due to the potential for serious adverse health consequences.

Plain-English summary

Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ BMB-BA006A Blood Glucose test strips. The recall is due to the product being inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips" rather than the correct product name.

The affected product is used with the Advocate Redi-Code+ BMB-EA004S meter to measure glucose in fresh capillary whole blood samples. The recall covers 1,852,800 cases of 50 strips each. These products were distributed nationwide in the United States and internationally to Venezuela, Ecuador, Canada, and Vietnam. The recall includes all test strip lots manufactured between June 1, 2012, and January 1, 2014.

Consumers should stop using the recalled test strips and contact the recalling firm for further instructions. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

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 fr

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.