# FDA recall Z-0193-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-10-06.

## Product

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

## Reason for recall

The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0193-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-06
- **Report date:** 2021-11-10

- **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-0193-2022

## Citation

> AI Analytics. FDA recall Z-0193-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0193-2022. Source: US FDA. Licensed CC0.

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