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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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