FDAFDA · Food and drugs·Recall number Z-2272-2012
Sunquest Laboratory LabAccess Results Workstation (LARS)
Published September 5, 2012 · Recall initiated: October 5, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sunquest Information Systems, Inc.
- Distributor
- Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
- Lot
- Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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