Sunquest Laboratory Software Recall for Calculation Errors in Online Entry
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4.0 and later due to potential calculation errors in the Online Entry application.
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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or software issues without reported harm.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory software, versions 6.4.0 and later. The software is intended for use by professionals working in a clinical laboratory. The recall covers 127 sites with nationwide distribution.
The recall was initiated because online calculations may not be performed as expected or may yield results that are different than expected. This issue occurs when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences. No specific instructions for consumers are provided in the source text, but the affected software is used by clinical laboratory professionals.
The recalled product
- Product
- Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
- Manufacturer
- Sunquest Information Systems, Inc.
- Hazard
- Affected units
- 127
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)
- Versions 6.4.0 and later
Distribution
Distributed nationwide across the United States.
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