Nova Diabetes Care is voluntarily recalling 21 lots of glucose test strips marketed around the world because they may generate a bogus report of abnormally high blood sugar.
A chemical contaminated the strips during manufacturing, leading to the malfunction, the FDA said, creating a risk that patients will grab for an insulin dose after the glucose test strip reading when they don't need one. The FDA is concerned enough that it announced the voluntary recall directly--an unusual move. Regulators and the company estimate that as many as 62 million test strips are affected by the recall.
Test strips marketed under the name "Nova Max Blood Glucose Test Strips" and the "Nova Max Plus Glucose Meter Kits" are affected by the recall, which the company itself announced on July 26. Nova made the products from December 2011 through April 2013 and sold them in retail stores and directly to consumers online in the United States, Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica, Puerto Rico, the United Kingdom, Germany, Belgium, Finland, Congo and Saudi Arabia.
Patients are urged to log onto Nova's web site if they have the affected product, or contact the company directly.
A number of companies have struggled with quality issues affecting their diabetes-care devices. Among the major ones: Medtronic ($MDT) recently issued four warnings concerning problems with its SynchroMed infusion pump that led to an FDA Class I recall and 14 deaths over 17 years. Earlier this year, Johnson & Johnson's ($JNJ) Animas division recalled its 2020 devices (which also have the FDA's Class I recall status), warning that a malfunction could lead to unintended insulin delivery. Abbott ($ABT) also got hit with a Class I label on a recall involving its FreeStyle InsuLinx blood glucose meters in the U.S., warning they could give an inaccurate reading at extremely high blood glucose levels.
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