Sunquest Information Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2332-2012 | Class II | Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinica | March 15, 2012 |
| Z-2270-2012 | Class II | Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry | December 5, 2011 |
| Z-0073-2013 | Class III | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | November 15, 2011 |
| Z-0250-2013 | Class II | Sunquest Laboratory, version 7.0 not available | November 3, 2011 |
| Z-2229-2012 | Class III | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use | August 12, 2011 |
| Z-2216-2012 | Class III | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select | April 28, 2011 |
| Z-2272-2012 | Class II | Sunquest Laboratory LabAccess Results Workstation (LARS) | October 5, 2010 |
| Z-0251-2013 | Class II | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and la | November 19, 2009 |
| Z-2243-2012 | Class III | Sunquest Encompass The reporting site is using the Encompass software in an acute patient care se | April 13, 2009 |