SoftLab Software Recalled for Incorrect Lab Result Display
Soft Computer Consultants is recalling SoftLab Software versions 4.5.4.3 through 4.5.5.20 because it may display lab results based on incorrect LOINC codes.
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 is classified as FDA Class II. The hazard involves incorrect display of lab results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Soft Computer Consultants, Inc. is recalling 18 units of SoftLab Software, a laboratory information system used in medical research or clinical laboratories. The recall affects specific software versions, including 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20.
The recall was initiated because the software may display lab results based on incorrect LOINC codes or test descriptions. This issue occurs for tests performed at a reference lab that were saved incorrectly and subsequently sent to systems that display the Electronic Medical Record (EMR).
The affected software was distributed in the United States to the states of California, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Pennsylvania, and Texas. Users of the affected software versions should contact the manufacturer for instructions on correcting the data or updating the system.
The recalled product
- Product
- SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
- Manufacturer
- Soft Computer Consultants, Inc.
- Affected units
- 18
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 (11)
- Versions 4.5.4.3
- 4.5.4.5
- 4.5.4.6
- 4.5.4.8
- 4.5.4.9
- 4.5.4.20
- 4.5.4.30
- 4.5.4.40
- 4.5.5.0
- 4.5.5.10
- and 4.5.5.20
Distribution
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