The U.S. Food and Drug Administration has cautioned diabetes patients that up to 62 million Nova Biomedical Corp. glucose test strips were contaminated during manufacturing and can give false readings leading to insulin dosing errors. The FDA announced that 21 lots of Nova Max Blood Glucose Test Strips manufactured as early as 2011 had been recalled after it was discovered they could register false, abnormally high blood glucose readings. Nova Max Plus Glucose Meter Kits, sold separately, also included test strips from the recalled lots, according to the company.
The products were distributed in the U.S., Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica, Puerto Rico, the U.K., Germany, Belgium, Finland, Congo and Saudi Arabia. According to the FDA, the company’s other diabetes product lines were not found to have been affected. Patients using the strips could see artificially high blood glucose levels, the FDA said. The false readings could purportedly result in patients administering insulin doses to treat nonexistent glucose elevations, which could necessitate immediate medical attention. Alberto Gutierrez, a director in the FDA’s Center for Devices and Radiological Health, said:
It’s important that patients using these test strips discontinue their use immediately. A false reading could result in patient harm and delay critical care.
The defective strips were manufactured between December 2011 and April, according to the company, and became contaminated with an unnamed chemical used during the manufacturing process. The strips are sold in retail stores and online directly to consumers, and are also used in health care facilities. The FDA is working with Nova to investigate the problem and ensure that it doesn’t recur. At press time, the source of the contamination had not been fully determined.
Nova has laid out procedures for wholesale pharmaceutical buyers and diabetes patients to obtain replacements if their strips are found to have come from a contaminated lot. The FDA says that if consumers must use compromised strips before the new ones arrive, they should perform a quality-control test using solution that is included with the products first.
The FDA says further that patients should verify all elevated blood glucose test results that are not consistent with their diabetes history by repeating the same test using a new test strip from a different vial. In 2010, Johnson & Johnson unit LifeScan Inc. recalled eight lots of its OneTouch SureStep test strips — about 14,000 units — because the strips could produce falsely low readings. Later that year, Abbott Diabetes Care recalled approximately 359 million test strips that also gave falsely low glucose results.
Source: Law 360
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