Merge LIS software — Class II medical device recall Z-2628-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-07-05, distributed nationwide. There are potential issues with results reporting for certain run-based tests. Under certain conditions, the w
| Recall number | Z-2628-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2017-06-23 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2019-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 638 sites |
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 for recall
There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2628-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.