Home / Recalls / Sunquest Information Systems, Inc. / Z-2216-2012

Z-2216-2012 Class III Terminated

Recalled by Sunquest Information Systems, Inc. — Tucson, AZ

Recall Details

Product Type
Devices
Report Date
August 22, 2012
Initiation Date
April 28, 2011
Termination Date
September 4, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
103 sites

Product Description

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Reason for Recall

In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or

Distribution Pattern

Nationwide Distribution

Code Information

Version 6.3.0 and Later

Other recalls by Sunquest Information Systems, Inc.

  • Z-2332-2012 Class II — Sunquest Laboratory Sunquest Laboratory is intended for use by professionals (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 (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: (August 12, 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 (November 19, 2009)
  • Z-2243-2012 Class III — Sunquest Encompass The reporting site is using the Encompass software in an a (April 13, 2009)