# FDA recall Z-0148-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-07-30.

## Product

Siemens Atellica CH 930 Analyzer.    Siemens Material Number (SMN): 11067000    Product Usage:  automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

## Reason for recall

Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

## Distribution

Worldwide Distribution - US Nationwide  Foreign:  Argentina  Australia  Austria  Bangladesh  Belgium  Brazil  Bulgaria  Canada  Chile  Colombia  Czech Republic  Denmark  Ecuador  Egypt  Finland  France  Germany  Greece  Hungary  India  Indonesia  Iran  Ireland  Israel  Italy  Japan  Kuwait  Latvia  Malaysia  Mexico  Netherlands  Nigeria  Norway  P.R. China  Pakistan  Philippines  Poland  Portugal  Qatar  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Singapore  Slovakia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Turkey  U.A.E.  United Kingdom  Uruguay  Vietnam

## Key facts

- **Recall number:** Z-0148-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-30
- **Report date:** 2019-10-23
- **Termination date:** 2022-06-10

- **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-0148-2020

## Citation

> AI Analytics. FDA recall Z-0148-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0148-2020. Source: US FDA. Licensed CC0.

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