Accu-Chek Aviva Plus Health Network Strips- intended for Blood… — Class II medical device recall Z-0997-2020
Terminated recall by Roche Diabetes Care, Inc., reported 2020-02-12, distributed nationwide. Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a de
| Recall number | Z-0997-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-02-05 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 82,332 vials |
| UPC / GTIN / UDI-DI | 00365702438101 |
| NDC | 65702-0438-10 |
| Lot numbers | 497864 |
| Model numbers | 06908349001 |
Product
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Reason for recall
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0997-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.