Device product
Sunquest Laboratory LabAccess Results Workstation (LARS)
Z-2272-2012
Product summary
- Event
- Event 62714
- Status
- Terminated
- Classification
- Class II
- Quantity
- 151 sites
- Official record key
device-enforcement:Z-2272-2012
Official wording
Reason: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.
Code information: Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
Distribution pattern: Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
Derived failure modes
-
Unknown
The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.