# FDA recall Z-0863-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-12-02.

## Product

Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

## Reason for recall

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain,   Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia,   Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait,   Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland,   Portugal, Qatar, Republic Korea, Romania, Russian Fed.  Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa,   Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E.  Ukraine, United Kingdom, Uruguay, Vatika City, Vietnam.

## Key facts

- **Recall number:** Z-0863-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-02
- **Report date:** 2021-01-20
- **Termination date:** 2024-06-06

- **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-0863-2021

## Citation

> AI Analytics. FDA recall Z-0863-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0863-2021. Source: US FDA. Licensed CC0.

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