Home / Recalls / Sunquest Information Systems, Inc. / Z-2270-2012

Z-2270-2012 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
September 5, 2012
Initiation Date
December 5, 2011
Termination Date
August 27, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
127 sites

Product Description

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Reason for Recall

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

Distribution Pattern

Worldwide Distribution -- USA (nationwide) and the country of Canada.

Code Information

Versions 6.4 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-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-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)