ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control — Class II medical device recall Z-2088-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-07-09, distributed nationwide. Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
| Recall number | Z-2088-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2025-06-04 |
| Classified | 2025-07-03 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,435 units |
| UPC / GTIN / UDI-DI | 00630414473390 |
| Lot numbers | TP252035, TP252045 |
Product
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Reason for recall
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
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-2088-2025. 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.