Recall Z-2093-2021— Soft Computer Consultants, Inc.
Class II · Terminated
Class II FDA medical device recall by Soft Computer Consultants, Inc., initiated 2021-03-31, terminated 2022-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.. Reason: Software showing wrong results reported, PDF not match HIS..
- Recalling firm
- Soft Computer Consultants, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-31
- Terminated
- 2022-04-15
- Firm location
- Clearwater, FL, United States
Product description
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Reason for recall
Software showing wrong results reported, PDF not match HIS.
Data sourced from openFDA. This site is unofficial and independent of the FDA.