Sunquest Laboratory Version 7.0 Recalled for Data Integrity Errors
Sunquest Information Systems is recalling Sunquest Laboratory version 7.0 because a software defect can cause user-defined data to be incorrectly replaced.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves data integrity errors rather than direct physical injury or death, fitting the Moderate severity criteria for software defects without reported harm.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory, version 7.0. The recall is due to a software defect where saving an Accession to a non-current Episode/Event can cause a User-Defined field to be incorrectly replaced by the current Episode/Event User-Defined data.
The affected software was distributed nationwide in the United States and internationally to Ireland. The recall covers 14 sites. The source text does not specify the exact names of the affected sites or the specific dates of distribution.
Consumers and healthcare facilities using this software should contact Sunquest Information Systems, Inc. for further instructions on how to resolve the data integrity issue. The source text does not provide specific contact details or remediation steps.
The recalled product
- Product
- Sunquest Laboratory, version 7.0 not available
- Manufacturer
- Sunquest Information Systems, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 14
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)
- not available
Distribution
Distributed nationwide across the United States.
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