Z-2272-2012 Class II Terminated
FDA device recall Z-2272-2012 was initiated by Sunquest Information Systems, Inc. on October 5, 2010 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 24, 2012). Affected quantity: 151 sites.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- October 5, 2010
- Termination Date
- August 24, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151 sites
Product Description
Sunquest Laboratory LabAccess Results Workstation (LARS)
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
Code Information
Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3