The Recall Desk

FDA (Devices) recall action 84119

Roche Diabetes Care, Inc. recalled 6 products on 2020-01-08

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-01-08
Critical
0
Units
1,366,819

Why these products were recalled

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • ModerateFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling 355,400 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 33 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.

    Product
    Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.

    Product
    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues

    Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems

    Roche Diabetes Care is recalling specific Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues.

    Product
    Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and…
    Category
    Distribution
    0 states