The Recall Desk
HighFDA (Devices)·Z-1038-2015·Announced 2015-02-11

SCC Soft Computer Recalls SoftLab Laboratory Information System Versions

SCC Soft Computer is recalling SoftLab versions 4.0.7.0 and 4.0.7.1 because the software fails to send abnormal flags for Reference Lab test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that fails to send abnormal flags for test results, creating a risk of harm to patients due to delayed clinical action, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

SCC Soft Computer is recalling 48 units of SoftLab with SA HIS versions 4.0.7.0 and 4.0.7.1. SoftLab is a laboratory information system designed for use in medical research or clinical laboratories. The affected software versions were released between December 13, 2013, and February 28, 2014.

The recall was initiated because the software interface fails to send abnormal flags for Reference Lab test results. This defect may prevent laboratory personnel from being alerted to abnormal test values in a timely manner.

The affected units were distributed nationwide in the United States, including in Ohio, Georgia, New Jersey, Wisconsin, Florida, New Hampshire, Illinois, New York, Indiana, California, Alabama, Virginia, Missouri, Michigan, Kentucky, Massachusetts, Pennsylvania, Colorado, Maine, Tennessee, Washington, Minnesota, South Dakota, Louisiana, North Carolina, and Nevada, as well as in Canada. Users of the affected software should contact SCC Soft Computer for further instructions on resolving the issue.

The recalled product

Product
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.
Manufacturer
SCC Soft Computer
Category
Medical Device — Laboratory Information System
Hazard
Affected units
48

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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