# FDA recall Z-0474-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-10-26.

## Product

Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens.  Siemens Material Number (SMN): 11066000

## Reason for recall

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, 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, Vatikancity, Vietnam.

## Key facts

- **Recall number:** Z-0474-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-26
- **Report date:** 2020-11-25
- **Termination date:** 2024-04-19

- **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-0474-2021

## Citation

> AI Analytics. FDA recall Z-0474-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0474-2021. Source: US FDA. Licensed CC0.

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