Home / Recalls / Soft Computer Consultants, Inc. / Z-2093-2021

Z-2093-2021 Class II Terminated

Recalled by Soft Computer Consultants, Inc. — Clearwater, FL

Recall Details

Product Type
Devices
Report Date
July 28, 2021
Initiation Date
March 31, 2021
Termination Date
April 15, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

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.

Distribution Pattern

US Distribution to: CA only

Code Information

Version 4.1.15.6

Other recalls by Soft Computer Consultants, Inc.

  • Z-2098-2021 Class II — SoftCytogenetics (March 31, 2021)
  • Z-2865-2017 Class II — SoftLab Software Laboratory information system to be used in a medical resear (May 31, 2017)
  • Z-1097-2017 Class II — SCC Soft Computer Softbank II software Product Usage: Supports single and mu (October 6, 2016)
  • Z-1098-2017 Class II — Softbank software Product Usage: Decision support software for transfusion s (October 6, 2016)