The Department of Health (DH) today (June 12) drew public attention to a safety alert concerning a glucose test strip called the BMB-BA006A Advocate Redi-Code+ blood glucose test strip. The test strip, manufactured by BroadMaster Bio-Tech Corp (BroadMaster) and distributed by Diabetic Supply of Suncoast, Inc (Suncoast), contains a labelling error which could result in confusion about the suitable meter models for this test strip.
The DH, through its routine surveillance on medical devices, noticed the above alert issued by the US Food and Drug Administration. According to the alert, the labelling error may lead users to believe they can use the Advocate Redi-Code+ BMB-BA006A blood glucose test strips with the Advocate Redi-Code blood glucose meters, model numbers TD-3223E, TD-4223E, TD-4223F, TD-4276 manufactured by Taidoc Technology Corp. But in fact the test strips concerned should only be used with the Advocate Redi-Code+ BMB-EA001S and EA001A blood glucose meters manufactured by BroadMaster.
The product distributor Suncoast is recalling the test strips to avoid confusion and the possible misuse of the test strips with unsuitable meters, which could lead to incorrect glucose results.
A spokesman for the DH explained that false blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia or hyperglycemia.
"The DH is investigating whether the affected blood glucose test strips have been imported into Hong Kong. People who are using the blood glucose test strip concerned should stop using the product," the spokesman said.
So far, the DH has not received any local report of adverse events arising from use of the product.
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