Sunquest Laboratory Software Recalled for Patient Data Merge Errors
Sunquest Information Systems is recalling specific versions of its Laboratory software because a merge function may cause receiving systems to incorrectly merge patient data.
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, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory software versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1. The recall involves 126 sites with distribution in the United States, England, the United Kingdom, and the United Arab Emirates.
The recall is due to a defect in the Windows-based merge application. When the "Event merge across patients" option is used, a receiving system, such as a Hospital Information System (HIS) or CoPath system, may interpret the event merge as a full patient merge. This occurs because of a trigger from the Laboratory system.
The software is intended for use by professionals working in a clinical laboratory who have received extensive training. The system manages laboratory processes including patient registration, order entry, specimen collection, and billing. The source text does not specify reported injuries, illnesses, or specific corrective actions for users.
The recalled product
- Product
- Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via…
- Manufacturer
- Sunquest Information Systems, Inc.
- Hazard
- Affected units
- 126
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 (5)
- Version versions 6.1.0125 through 6.1.0139
- 6.2.1
- 6.2.2
- 7.0
- and 7.0.1
Distribution
Distributed nationwide across the United States.
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Similar recalls
- LowSunquest Laboratory Software Recall for Calculation Errors in Online Entry
FDA (Devices) · 2012-10-24
- ModerateSunquest Laboratory Version 7.0 Recalled for Data Integrity Errors
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- ModerateSunquest Laboratory SMART Software Recall for Incorrect Patient Data
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