FDA recall Z-2093-2021

Soft Computer Consultants, Inc. · Class II · 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.

Reason for recall

Software showing wrong results reported, PDF not match HIS.

Distribution

US Distribution to: CA only

Key facts

Status
Terminated
Initiation date
2021-03-31
Report date
2021-07-28
Termination date
2022-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2021