Recall Z-2628-2017— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-15, terminated 2019-03-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-15
- Terminated
- 2019-03-13
- Firm location
- Hartland, WI, United States
Product description
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.
Reason for recall
There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Data sourced from openFDA. This site is unofficial and independent of the FDA.