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www.fdanews.com/articles/193528-tga-flags-risks-for-accu-chek-blood-glucose-meters

TGA Flags Risks for Accu-Chek Blood Glucose Meters

November 20, 2019

Australia’s Therapeutic Goods Administration announced product defects in the Accu-Chek Guide and Accu-Chek Performa blood glucose meters that could cause a delay in therapy.

Accu-Chek Guides with serial numbers lower than 92911000001 and Performa meters with serial numbers between 68920000000 and 68925525056 may display battery replacement indications, unexpectedly show the low battery icon, have short battery life and fail to turn on, the agency warned.

The errors could lead to serious medical issues for diabetic patients if therapy decisions are hindered by the device defects, the agency said.

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