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 is classified as FDA Class II. The hazard involves a delay in treatment decisions for a medical device, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diabetes Care, Inc. is recalling 92,836 vials of Accu-Chek Aviva Plus Retail Strips 50 ct (Catalog Number: 06908217001). The recall affects Lot Number 498315, NDC 65702-0407-10, and UPC 3-65702-40710-7. The product was distributed nationwide and in Australia and India.
The recall was initiated because the test strips may be unable to dose properly. This malfunction can result in a temporary inability to obtain a blood glucose result. Such a failure could lead to a delay in treatment or therapy decisions for patients relying on the device.
Consumers with this specific lot of test strips should stop using them and contact Roche Diabetes Care for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 92,836
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:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7
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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