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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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