The Recall Desk
ModerateFDA (Devices)·Z-2765-2019·Announced 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.

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, but the defect involves a power component (capacitor) causing functional failure (short battery life or not turning on) rather than a direct physical injury hazard like fire or shock. This aligns with moderate severity for functional defects without reported injuries.

Plain-English summary

Roche Diabetes Care, Inc. is recalling 26,600 units of the Accu-Chek Aviva II Meter. The recall is due to a potential defect where the meters may contain a damaged C29 capacitor. This issue can result in power allegations, specifically short battery life or the meter not turning on.

The affected products were distributed worldwide and nationwide in the United States. The recall covers specific serial numbers: between XXX20000000 and XXX23284925, or less than XXX06335297. Updated serial number ranges were provided on October 12, 2019, and October 18, 2019.

Consumers should check the serial number on their Accu-Chek Aviva II Meter to see if it is included in the recall. If the device is affected, users should contact Roche Diabetes Care for instructions on how to proceed.

The recalled product

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
Affected units
26,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial numbers between xxx20000000 and xxx23284925

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 →