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.

Recall Insight

This FDA Devices action (record #Z-2628-2017) was formally reported on July 5, 2017, with the manufacturer initiating the action on April 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records list the affected scope as 638 sites have the potentially affected versions.

The documented reason for this recall is: There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified. Distribution data in the federal record shows the product reached: Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.