The Recall Desk
ModerateFDA (Devices)·Z-2766-2019·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (power failure) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.

Plain-English summary

Roche Diabetes Care, Inc. is recalling Accu-Chek Performa II meters due to a potential defect in the C29 capacitor. This component may be damaged, which can result in power issues such as short battery life or the meter failing to turn on.

The recall covers meters with serial numbers between XXX20000000 and XXX25525056. The product was distributed nationwide in the United States and worldwide.

Consumers should check the serial number on their meter to see if it is affected. If the meter is included in the recall, users should stop using it and contact Roche Diabetes Care for instructions on how to proceed.

The recalled product

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →