# FDA recall Z-2628-2017

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2016-04-15.

## Product

Merge LIS software.  The firm name on the label is Merge Healthcare.    Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.

## Reason for recall

There are potential issues with results reporting for certain run-based tests.  Under certain conditions, the wrong results could inadvertently be verified.

## Distribution

Nationwide Distribution to  facilities and distributors.  Distribution was made to the Virgin Islands.  Foreign distribution was also made.  There was no military/government distribution.

## Key facts

- **Recall number:** Z-2628-2017
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-04-15
- **Report date:** 2017-07-05
- **Termination date:** 2019-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hartland, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2628-2017

## Citation

> AI Analytics. FDA recall Z-2628-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2628-2017. Source: US FDA. Licensed CC0.

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