Home / Recalls / Sunquest Information Systems, Inc. / Z-0073-2013

Z-0073-2013 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
October 24, 2012
Initiation Date
November 15, 2011
Termination Date
October 19, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
127 sites

Product Description

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

Reason for Recall

Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

Distribution Pattern

Nationwide distribution

Code Information

Versions 6.4.0 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-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-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 (November 19, 2009)
  • Z-2243-2012 Class III — Sunquest Encompass The reporting site is using the Encompass software in an a (April 13, 2009)