The Recall Desk

FDA (Devices) recall action 83574

Roche Diabetes Care, Inc. recalled 2 products on 2019-10-09

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-10-09
Critical
0
Units
26,600

Why these products were recalled

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

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.

1–2 of 2

  • ModerateFDA (Devices)··2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-10-09

    Roche Accu-Chek Performa II Meters Recalled for Damaged Capacitor

    Roche Diabetes Care is recalling Accu-Chek Performa II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The A
    Category
    Distribution
    0 states