Company: Merge Healthcare, Inc.
Date of Enforcement Report 7/5/2017
Class lI:

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.
Recall Number Z-2628-2017

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

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/15/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
638 sites potentially have the affected versions

DISTRIBUTION
US and internationally

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