Sunquest LabAccess Results Workstation Recalled for Incorrect Patient Data Filing
Sunquest Information Systems is recalling the LabAccess Results Workstation (LARS) because it may incorrectly file laboratory results to the wrong patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or adverse health consequences (such as misattribution of medical data) are rated as Severe (4).
Plain-English summary
Sunquest Information Systems, Inc. is recalling the Sunquest Laboratory LabAccess Results Workstation (LARS) software. The recall was initiated because the company confirmed that the software may file results to the wrong patient by incorrectly combining results.
The affected software versions are 5.3.3 and 6.3.0 SP3. The product was distributed worldwide, including in the United States, Canada, Denmark, Ireland, the United Arab Emirates, and the United Kingdom. A total of 151 sites are affected by this recall.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Consumers and healthcare facilities should contact Sunquest Information Systems for further instructions on how to address the software defect.
The recalled product
- Product
- Sunquest Laboratory LabAccess Results Workstation (LARS)
- Manufacturer
- Sunquest Information Systems, Inc.
- Affected units
- 151
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)
- Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
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
- ModerateSunquest Laboratory Software Recall for Microbiology Data Entry Errors
FDA (Devices) · 2012-09-05
Same hazard · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSunquest Laboratory Software Recalled for Patient Data Merge Errors
FDA (Devices) · 2012-09-19
- LowSunquest Laboratory SMART Software Recalled for Test Result Filing Errors
FDA (Devices) · 2012-08-22
- 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
FDA (Devices) · 2012-11-14
- ModerateSunquest Laboratory SMART Software Recall for Incorrect Patient Data
FDA (Devices) · 2012-08-29
- HighMerge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification
FDA (Devices) · 2017-07-05