FDA Device recall Z-2341-2019
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Sieme…
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Sieme… by Siemens Healthcare Diagnostics, citing iincreased (falsely elevated) Albumin results compared to expected results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2341-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-27 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
Iincreased (falsely elevated) Albumin results compared to expected results
Identifiers
| code_info | Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2341-2019%22
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