Nipro Diagnostics, Inc. today announced it is initiating a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both in the United States and outside the United States. The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed in the United States have an incorrect factory-set unit of measure that displays the glucose result in mmoi/L rather than mg/dl.
Tonia’s Biscotti II LLC of Homer, AK is recalling Sampler Bags, Lemon Biscotti dipped in White Chocolate Bags, and individually wrapped biscotti of all flavors because they may contain undeclared wheat, milk, and soy. People who have an allergy or severe sensitivity to wheat, milk, and/or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
The fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.