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