Recalled Nova Max Glucose Test Strips Can Cause Injury, Death: FDA
Federal health regulators have determined that the continued use of the recently recalled Nova Max glucose test strips could pose a reasonable probability of significant injury or death for diabetic users.
On July 26, 21 lots of Nova Max Plus glucose test strips were recalled after the manufacturer recognized the kits may provide false and abnormally high blood glucose levels and cause insulin dosing errors.
This week the FDA categorized the action as a Class I medical device recall, due to the substantial risk faced by diabetics who may receive results showing high blood glucose levels from the product, potentially resulting in hypoglycemia, seizures, unconsciousness, brain damage, and even death from improper insulin levels.
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Users have been urged to recognize the potential symptoms for high blood sugar, which typically involve excessive urination, excessive thirst, nausea, vomiting, weakness, and abdominal pain. Symptoms of low blood sugar usually include consistent headaches, sweating, trembling, and in some cases individuals may experience unconsciousness or seizures.
The test strips were manufactured by Nova Biomedical Corporation of Waltham, Massachusetts from December 2011, through April 2013, and distributed from January 2012, through July 23, 2013.
The FDA is recommending that consumers should stop using the recalled glucose test strips immediately and consult with their healthcare provider. Users are encouraged to resort to an alternative method of measuring blood glucose levels until replacement strips are provided by Nova Biomedical Corporation.
Those with the recalled glucose test strips should contact Nova Biomedical Corp. at 1-800-681-7390 to receive further instructions on how to replace the affected test strips.
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