Recall Z-2628-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Merge Healthcare, Inc.
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.
| Date | May 25, 2017 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified. |
| Root cause | Software design |
| Action | 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 envelop |
| Quantity | 638 sites have the potentially affected versions |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.