# FDA recall Z-2091-2023

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2023-05-16.

## Product

Aptio Automation Storage and Retrieval Module (SRM)

## Reason for recall

A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result.     The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other:      - The SRM module is releasing a sample tube (Tube A) just placed into the carrier      - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer     - There is divert gate malfunction and a narrow timing window    Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated.   The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, & United Kingdom.

## Key facts

- **Recall number:** Z-2091-2023
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-16
- **Report date:** 2023-07-12

- **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-2091-2023

## Citation

> AI Analytics. FDA recall Z-2091-2023. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2091-2023. Source: US FDA. Licensed CC0.

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