Sorry we missed sharing this earlier:
Recall Class: Class I
Date Recall Initiated: June 6, 2014
Products: Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – All Lots
Distribution Dates: January, 2012 – June 6, 2014
Use: The Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips are used at home by people with diabetes to monitor their blood glucose levels. Blood glucose test strips measure the amount of glucose (sugar) in a blood sample collected by pricking the skin.
Diabetic Supply of Suncoast, Inc.
Barrio Espinosa Road #2 Km 26.2
Dorado, PR 00646
BroadMaster Bio-Tech Corp.
7f, No. 168-2, Liancheng
Zhonghe City, Taipei County, Taiwan 23553
Reason for Recall:
A labeling error omitting the test strips model number (BMB-BA006A) could lead to use of the Advocate Redi-Code+ BMB-BA006A blood glucose test strips manufactured by BroadMaster Bio-Tech Corp. with the incorrect glucose meters.
Suncoast is recalling the test strips to avoid confusion and possible misuse of the test strips with the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp. Misuse could result in incorrect glucose test results.
Falsely high or falsely low glucose results could potentially cause missed or delayed high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia) detection and lead to no treatment or inappropriate treatment.
Delayed or inappropriate treatment of high blood sugar or low blood sugar may lead to serious adverse health consequences, including death.
For more information (including pictures of the incorrect and correct labeling), see the firm’s press release.
Public Contact: Customers may contact Diabetic Supply of Suncoast at (561) 296-0488 between 9:00 a.m. and 5:00 p.m., Monday through Friday, Eastern Time or view the information at www.dsosi.com.
FDA District: Puerto Rico District Office