# FDA recall Z-2341-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-06-27.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2341-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-27
- **Report date:** 2019-08-28
- **Termination date:** 2020-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2019

## Citation

> AI Analytics. FDA recall Z-2341-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2341-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*