# FDA recall Z-1797-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-02-27.

## Product

Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower

## Reason for recall

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the  save  button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

## Distribution

US Nationwide.  Global distribution.

## Key facts

- **Recall number:** Z-1797-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-27
- **Report date:** 2020-05-06
- **Termination date:** 2021-10-25

- **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-1797-2020

## Citation

> AI Analytics. FDA recall Z-1797-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1797-2020. Source: US FDA. Licensed CC0.

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