Laboratory Information System SoftGenomics Recalled for Displaying Incorrect Results
SoftGenomics version 4.1.15.6, a laboratory information system used in clinical laboratories, has been recalled due to reports that the software displays incorrect results and PDF reports do not match the hospital information system.
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: This is an FDA Class II medical device recall. The hazard is data accuracy and system-record mismatch in a clinical laboratory system. No illnesses or injuries have been reported. The software failure represents a risk of harm to patients whose care depends on accurate lab results, but without reported adverse outcomes, this meets the High (score 3) criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
SoftGenomics version 4.1.15.6 is a laboratory workflow and information management system designed for use in clinical molecular, cytogenetics, or medical research laboratories. It is used to record and track activities in specimen ordering, processing, testing, documentation, and reporting.
The software has been recalled because it was reported to display incorrect results and generate PDF reports that do not match records in the hospital information system. This discrepancy could compromise the accuracy of laboratory documentation and test reporting.
The recalled version was distributed in California. Laboratories using SoftGenomics version 4.1.15.6 should contact Soft Computer Consultants, Inc. for information regarding this recall.
The recalled product
- Product
- 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…
- Manufacturer
- Soft Computer Consultants, Inc.
- Affected units
- 1
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)
- Version 4.1.15.6
Distribution
Distributed in 1 state:
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