Merge Healthcare, Inc. recalls Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for orderi

Recalled July 5, 2017 · FDA recall Z-2628-2017 · Merge Healthcare

Hazard

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

Units

638 sites have the potentially affected versions

Sold at

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

Description

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

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.

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →