Accu-Chek Inform II Test Strip — Class II medical device recall Z-2354-2021
Ongoing recall by Roche Diabetes Care, Inc., reported 2021-09-01, distributed nationwide. Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test stri
| Recall number | Z-2354-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2021-07-28 |
| Classified | 2021-08-26 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Model numbers | 05942891001 |
Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Reason for recall
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
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-2354-2021. 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.