Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Merge LIS software. The firm name on the label is Recalled by Merge Healthcare, Inc. Due to There are potential issues with results reporting for...

Date: April 15, 2016
Company: Merge Healthcare, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.

Affected Products

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.

Quantity: 638 sites have the potentially affected versions

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Merge Healthcare, Inc.

Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report