SoftCytogenetics Software Recalled for Incorrect Test Result Transmission
Soft Computer Consultants, Inc. is recalling SoftCytogenetics software (versions 4.1.11.20, 4.1.12.11, 4.1.15.6) distributed in CA, FL, MN, and NJ because it produces incorrect results for retested specimens that are transmitted to clinical information systems.
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: FDA Class II recall for medical device software that produces and transmits incorrect test results to clinical systems. While no illnesses or injuries are reported in the source, the active transmission of inaccurate clinical data creates a direct risk of patient harm through incorrect diagnoses or treatment decisions.
Plain-English summary
Soft Computer Consultants, Inc. is recalling SoftCytogenetics software versions 4.1.11.20, 4.1.12.11, and 4.1.15.6. The recall affects healthcare facilities nationwide, with confirmed distribution in California, Florida, Minnesota, and New Jersey.
The software produces incorrect results for test samples that have undergone reanalysis (reruns). These incorrect results are transmitted to hospital information systems (HIS), where they may be used in clinical decision-making.
Healthcare facilities using affected versions should contact Soft Computer Consultants, Inc. for guidance on remediation and verification of results. Clinical staff should carefully review any test results generated by the affected software versions, particularly for samples that were retested.
The recalled product
- Product
- SoftCytogenetics
- Manufacturer
- Soft Computer Consultants, Inc.
- Affected units
- 5
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 (2)
- Versions: 4.1.11.20
- 4.1.12.11 and 4.1.15.6
Distribution
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