Roche Recalls Accu-Chek Aviva Plus Blood Glucose Test Strips
Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device defect that could delay critical treatment decisions, fitting 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 82,332 vials of Accu-Chek Aviva Plus Health Network Strips, intended for use with the Blood Glucose Monitoring System. The affected product has Catalog Number 06908349001, Lot Number 497864, NDC 65702-0438-10, and UPC 3-65702-43810-1.
The recall was initiated because the test strips may be unable to dose properly. This defect could result in a temporary inability to obtain a blood glucose result, which may lead to a delay in treatment or therapy decisions for patients relying on the device.
The affected units were distributed nationwide in the United States as well as in 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.
The recalled product
- Product
- Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 82,332
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: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
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.
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