N Cuvette Segments for BN ProSpec System-IVD a system for the… — Class II medical device recall Z-2341-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-08-28, distributed nationwide. Iincreased (falsely elevated) Albumin results compared to expected results
| Recall number | Z-2341-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-06-27 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 664 units |
| UPC / GTIN / UDI-DI | 00842768012334 |
| Lot numbers | 182670004, 5890128326 |
Product
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Reason for recall
Iincreased (falsely elevated) Albumin results compared to expected results
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-2341-2019. 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.