SCC Soft Computer: Medical Device Recall in 2015 - (Recall #: Z-1038-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

Product Classification:

Class II

Date Initiated: May 20, 2014

Date Posted: February 11, 2015

Recall Number: Z-1038-2015

Event ID: 70021

Reason for Recall:

The interface fails to send abnormal flags for Reference Lab test results.

Status: Terminated

Product Quantity: 48

Code Information:

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Distribution Pattern:

Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated