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| The FDA has assigned its most serious warning to Nova Diabetes Care's test strip recall.--Courtesy of Nova |
Using some test strips shipped with a Nova Diabetes Care glucose meter could put patients at risk for serious adverse events or death, according to the FDA, and the company is warning patients to immediately stop using the affected devices.
Late last month, Nova sent a letter to its customers advising that 21 lots of its Nova Max test strips could, under certain conditions, report falsely high blood glucose readings.
That could lead to errant insulin dosing and hypoglycemia, and, on Wednesday, the FDA slapped its most-serious Class I label on the recall, cautioning that using the strips could put patients in serious danger.
Nova is telling patients to halt using the test strip lots it identified in a letter and ship them back to the company for free replacements. Meanwhile, the FDA is asking for reports of related adverse events through its online MedWatch platform.
The recall affects as many 62 million strips, the FDA said, and Nova distributed the devices in 14 countries over about 18 months.
The company has traced the problem to a chemical contamination in the manufacturing process at its Massachusetts headquarters, and the recall has no effect on any of its other products.
- read the FDA's note