SCC Soft Computer Recalls SoftMic Laboratory Information System Software
SCC Soft Computer is recalling SoftMic version 4.0.7.0 because missing SNOMED codes may cause incomplete patient data and delayed treatment updates.
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 risk-of-harm product (medical software) where injury has not yet been reported, but the potential for delayed patient treatment updates exists.
Plain-English summary
SCC Soft Computer is recalling SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system used in medical, clinical, and public health laboratories to manage data for microbiology and serology testing.
The recall is due to a software issue where isolate information may be incomplete or missing in downstream systems if an isolate is resulted without a SNOMED code. This defect creates the potential for delays or omissions in patient treatment updates.
The affected software was distributed in Illinois. Users of this specific software version should contact SCC Soft Computer for further instructions on resolving the issue.
The recalled product
- Product
- SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data…
- Manufacturer
- SCC Soft Computer
- 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)
- SA HIS version 4.0.7.0
Distribution
Distributed in 1 state:
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