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Recall Observatory FDA recall evidence

Device 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.

Z-2628-2017

April 15, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77299
Status
Terminated
Classification
Class II
Quantity
638 sites have the potentially affected versions
Official record key
device-enforcement:Z-2628-2017

Official wording

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

Code information: Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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