Sunquest Laboratory SMART Software Recalled for Test Result Filing Errors
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.3.0 and later because test results may be filed to the wrong patient containers.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the source text describes a data filing error rather than a direct physical hazard.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory SMART and Sunquest Laboratory SMART Select software, version 6.3.0 and later. The recall involves 103 sites with nationwide distribution.
The recall is due to a software defect in Online Entry (OEx) where test results from one container may be filed to a test on another container. This error occurs when specific site parameters are set to restrict results to the owner container, tests are ordered on the same accession number, and test codes are defined with the same upload code as either replicate.
Healthcare facilities using these software versions should contact Sunquest Information Systems for further instructions on correcting the software configuration or applying patches to prevent incorrect test result filing.
The recalled product
- Product
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- Manufacturer
- Sunquest Information Systems, Inc.
- Hazard
- Affected units
- 103
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 6.3.0 and Later
Distribution
Distributed nationwide across the United States.
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