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News & Trends - MedTech & Diagnostics

Roche correcting blood glucose monitor defects

Health Industry Hub | November 15, 2019 |

Healthcare professionals and consumers are advised that Roche Diabetes Care Australia, in consultation with the Therapeutic Goods Administration (TGA), is undertaking a product defect correction for Accu-Chek Guide and Accu-Chek Performa blood glucose meters.

It has been identified that Accu-Chek Guide blood glucose meters with serial numbers lower than 92911000001 and Accu-Chek Performa blood glucose meters with serial numbers between 68920000000 and 68925525056 (see image for serial number placement on the back of the meter) may:

  • Display E-9 Errors (indicating that the batteries need to be replaced)
  • Unexpectedly display the low battery icon
  • Have short battery life
  • Not power on.

If any of the above issues occur, it can lead to temporary meter unavailability that could cause a delay in therapy decisions, which in turn could lead to a serious medical issue.

Accu-Chek Guide and Accu-Chek Performa
blood glucose meters

The TGA Safety Advisory can be found at: https://www.tga.gov.au/alert/accu-chek-guide-and-accu-chek-performa-blood-glucose-meters

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