FDA Device recall Z-1038-2015
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical labora…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical labora… by Scc Soft Computer, citing the interface fails to send abnormal flags for Reference Lab test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1038-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Scc Soft Computer |
| Distribution | US |
Product
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Reason
The interface fails to send abnormal flags for Reference Lab test results.
Identifiers
| code_info | 4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1038-2015%22
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