# FDA recall Z-0189-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-06-29.

## Product

Atellica Sample Handler Prime (SMN 11069001).    The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

## Reason for recall

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified:  1.	Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time.  2.	Sample barcodes may be incorrectly read  3.	The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior.      4.	The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed.  5.	The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.

## Distribution

Nationwide  Foreign:  Australia  Austria  Belgium  Brazil  Canada  Croatia  Czech Republic  Denmark  France  Germany  Greece  Italy  Japan  Malaysia  Mexico  Netherlands  Norway  Poland  Republic Korea  Singapore  Spain  Sweden  Switzerland  U.A.E.  United Kingdom

## Key facts

- **Recall number:** Z-0189-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-29
- **Report date:** 2018-10-24
- **Termination date:** 2021-08-12

- **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-0189-2019

## Citation

> AI Analytics. FDA recall Z-0189-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0189-2019. Source: US FDA. Licensed CC0.

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