Jul

2017

Merge LIS software Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Merge LIS software Cl II

Amy Sellers

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