# FDA recall Z-2014-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-05-18.

## Product

The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.

## Reason for recall

ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of  2; an erroneously elevated or depressed patient result to be reported without alert on the test result

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, MA,  MD, MI, MN, NY, OH, PA, TX and the countries of Australia, Bahrain, Brazil, Canada, Chile,  Croatia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Netherlands, New Zealand, Norway, P.R. China,  Portugal, Republic Korea, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-2014-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-18
- **Report date:** 2021-07-14
- **Termination date:** 2024-08-30

- **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-2014-2021

## Citation

> AI Analytics. FDA recall Z-2014-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2014-2021. Source: US FDA. Licensed CC0.

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