FDA Device recall Z-2865-2017
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained by Soft Computer Consultants, citing display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2865-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-31 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Soft Computer Consultants |
| Distribution | CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, TX |
Product
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Reason
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Identifiers
| code_info | Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2865-2017%22
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