# FDA recall Z-2405-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-05-07.

## Product

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

## Reason for recall

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

## Distribution

Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.

## Key facts

- **Recall number:** Z-2405-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-05-07
- **Report date:** 2020-07-01

- **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-2405-2020

## Citation

> AI Analytics. FDA recall Z-2405-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2405-2020. Source: US FDA. Licensed CC0.

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