Recall Z-1038-2015— SCC Soft Computer
Class II · Terminated
Class II FDA medical device recall by SCC Soft Computer, initiated 2014-05-20, terminated 2016-05-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- SCC Soft Computer
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-20
- Terminated
- 2016-05-16
- Firm location
- Clearwater, FL, United States
Product description
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 for recall
The interface fails to send abnormal flags for Reference Lab test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.