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