# FDA recall Z-0175-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-05-23.

## Product

Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920,  Product Code KC716; IVD

## Reason for recall

Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L].   PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).

## Distribution

Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada,  France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

## Key facts

- **Recall number:** Z-0175-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-23
- **Report date:** 2017-12-06
- **Termination date:** 2018-03-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2018

## Citation

> AI Analytics. FDA recall Z-0175-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0175-2018. Source: US FDA. Licensed CC0.

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