# FDA recall Z-1586-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-02-26.

## Product

Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.

## Reason for recall

When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

## Distribution

FL   and  France  Spain  Sweden  United Kingdom  Germany

## Key facts

- **Recall number:** Z-1586-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-26
- **Report date:** 2018-05-09
- **Termination date:** 2020-05-12

- **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-1586-2018

## Citation

> AI Analytics. FDA recall Z-1586-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1586-2018. Source: US FDA. Licensed CC0.

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