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FDA Announces Voluntary Recall of Blood Glucose Test Strips
The FDA is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. Nova Diabetes Care announced a recall on July 26, 2013.
The recall pertains to certain lots of these test strips distributed in the U.S., Canada, and several other countries. As many as 62 million strips may be affected by the recall.
The test strips under recall may report a false, abnormally high blood glucose result. Under certain conditions, a false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.
The test strips, which were manufactured from December 2011 to April 2013, are sold in retail stores and online directly to consumers, and are used in health care facilities. The strips became contaminated with a chemical used during the manufacturing process. The FDA is working with Nova to investigate the problem and to prevent it from recurring.
Source: FDA; July 31, 2013.