Home / Recalls / Soft Computer Consultants, Inc. / Z-2098-2021

Z-2098-2021 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
February 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

SoftCytogenetics

Reason for Recall

Software is given wrong results going out to HIS on test that had reruns.

Distribution Pattern

US Nationwide Distribution in the states of CA, FL, MN and NJ.

Code Information

Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6

Other recalls by Soft Computer Consultants, Inc.

  • Z-2093-2021 Class II — SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and infor (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)