After Nova Biomedical issued a voluntary recall letter for its Nova Max test strips and glucose meter kits, the FDA determined that the measure qualified as a Class I recall, a label reserved for issues that pose a threat of significant patient harm.
Nova warned that the products might display a false, abnormally high blood glucose results, prompting inappropriate insulin dosing by the patient. Nova Max strips and other products are sold directly to patients at large retailers like CVS, Rite Aid and Walmart and through mail-order services for diabetics.
Nova sent a letter to affected customers last month, warning them to immediately stop using affected products, which include 19 lots of the glucose strips and 60 lots of the monitoring kits.
The Waltham, Mass.-based company will ship its customers new replacement kits and asked customers to use other products to manage their blood glucose in the meantime.
"Under certain conditions a false, abnormally high blood glucose level could result in an insulin dosing error that may lead to low blood glucose (hypoglycemia) requiring the user to seek immediate medical attention," according to the FDA recall notice.
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