Device 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.
Z-2093-2021
Product summary
- Event
- Event 88095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2093-2021
Official wording
Reason: Software showing wrong results reported, PDF not match HIS.
Code information: Version 4.1.15.6
Distribution pattern: US Distribution to: CA only
Derived failure modes
-
Unknown
Software showing wrong results reported, PDF not match HIS.