RocheDiabetes Care Platform Software version 2 — Class II medical device recall Z-1008-2022
Terminated recall by Roche Diabetes Care, Inc., reported 2022-05-04, distributed nationwide. Potential for patient data mismatch when using browser "back" button to navigate between patients when using t
| Recall number | Z-1008-2022 |
|---|---|
| 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 | 2022-03-09 |
| Classified | 2022-04-26 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 81 registered |
| Reason classes | software |
Product
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Reason for recall
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
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-1008-2022. 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.