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.
What this means for you
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.
Related recalls
Same manufacturer · Sunquest Information Systems, Inc.
See all →- ModerateSunquest Laboratory Version 7.0 Recalled for Data Integrity Errors
FDA (Devices) · 2012-11-14
- HighSunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination
FDA (Devices) · 2012-11-14
- LowSunquest Laboratory Software Recall for Calculation Errors in Online Entry
FDA (Devices) · 2012-10-24
- ModerateSunquest Laboratory Software Recalled for Patient Data Merge Errors
FDA (Devices) · 2012-09-19
- SevereSunquest LabAccess Results Workstation Recalled for Incorrect Patient Data Filing
FDA (Devices) · 2012-09-05
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereMedline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03