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.
This recall has been terminated (originally issued May 25, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 15, 2016
- Posted
- May 25, 2017
- Terminated
- March 13, 2019
- Recall Number
- Z-2628-2017
- Quantity
- 638 sites have the potentially affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.
Lot / Code Info
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
Root Cause
Software design
Action Taken
Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it is made available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 29, 2016. For further questions, call (877) 741-5369.