Company: Soft Computer Consultants, Inc.
Date of Enforcement Report: 7/28/2021
Class II
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.
Recall Number: Z-2093-2021
REASON
Software showing wrong results reported, PDF not match HIS.
RECALLING FIRM/MANUFACTURER
Soft Computer Consultants, Inc. on 3/31/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
U.S. Nationwide