# FDA recall Z-1301-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-03-07.

## Product

Atellica Sample Handler Prime, Material Number 11069001

## Reason for recall

There were multiple issues identified in the system software which required an update.

## Distribution

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico.    The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.

## Key facts

- **Recall number:** Z-1301-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-05-15
- **Termination date:** 2020-08-20

- **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-1301-2019

## Citation

> AI Analytics. FDA recall Z-1301-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1301-2019. Source: US FDA. Licensed CC0.

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