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| Nipro Diagnostics is recalling certain models of its TrueBalance glucose meter.--Courtesy of Nipro |
Japanese giant Nipro Diagnostics is pulling some of its glucose meters off the shelf over a unit-of-measure error that could lead customers to misread them and misunderstand blood sugar levels.
About 500 total TrueBalance and TrueTrack meters are affected, Nipro said, as a factory error left the devices displaying blood glucose in millimoles per liter, not the more common milligrams per deciliter. If a user doesn't notice the difference, he or she might believe glucose levels are much lower than they are, the company said.
Nipro is now asking customers with affected to devices to return them for a replacement. The company said it hasn't heard of any adverse events tied to the display issue. The FDA is aware of the voluntary recall, according to Nipro, but the agency is yet to weigh in on the effort.
The recall is unlikely to have a meaningful effect on earnings for the well-diversified company. Nipro hauled in $1.4 billion in sales in the 6 months that ended Sept. 30, and the company's medical device segment accounted for $1.1 billion of that. In addition to its fleet of diabetes and dialysis devices, Nipro makes money off of Japanese commercial rights to stateside inventions including Thoratec's ($THOR) HeartMate II and Infraredx's TVC imaging system.
- read the statement