Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Iincreased (falsely elevated) Albumin results compared to expected results |
| 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 |
| Quantity | 664 units |
| Distribution | Nationwide |
| Initiated | 2019-06-27 |
| Classified | 2019-08-22 |
| Terminated | 2020-05-27 |
| Recall number | Z-2341-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-2341-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83311/
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