Roche Accu-Chek Aviva Test Strips Recalled for Dosing Issues
Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in treatment decisions due to inability to obtain results, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diabetes Care, Inc. is recalling 61,329 units of ACCU-CHEK AVIVA ASPAC STRIP 50CT (Catalog Number: 06453970020, Lot Number: 498287). These test strips are intended for use with the Blood Glucose Monitoring System. The recall was initiated because the test strips may be unable to dose properly.
The inability to dose the test strips may result in a temporary inability to obtain a blood glucose result. This issue could lead to a delay in treatment and/or therapy decisions for patients relying on the device. The affected units were distributed nationwide and in foreign markets, including Australia and India.
Consumers who have these specific test strips should stop using them and contact Roche Diabetes Care for further instructions or a replacement. Patients should consult their healthcare provider if they are unable to obtain blood glucose readings.
The recalled product
- Product
- ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 61,329
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)
- Lot Number: 498287
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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