Sunquest Laboratory Software Recall for Microbiology Data Entry Errors
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4 and later due to potential errors in specimen data entry.
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 hazard involves data integrity errors (missing or wrong information) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Sunquest Information Systems, Inc. is recalling Sunquest Laboratory software versions 6.4 and later that utilize the Microbiology Result Entry (MRE) feature. The recall was initiated because the company confirmed that the specimen ribbon, which contains the Accession Number and Battery Name, may be missing or contain incorrect information.
The affected software was distributed nationwide in the United States and in Canada, impacting 127 sites. This issue involves the accuracy of data entry within the laboratory information system rather than a physical defect in a medical device.
Healthcare facilities using this software should contact Sunquest Information Systems for further instructions on how to address the data integrity issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
- Manufacturer
- Sunquest Information Systems, Inc.
- 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 and later
Distribution
Distributed nationwide across the United States.
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