FDA Device recall Z-1008-2022
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
- FDA Device
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001 by Roche Diabetes Care, citing potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1008-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-09 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
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
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
Identifiers
| code_info | Date of manufacture: 2021-11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
All Roche Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.