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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description Sunquest Laboratory LabAccess Results Workstation (LARS)
Recall Number Z-2272-2012
Classification Class II
Code Info Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
Product Distributed Qty 151 sites
Reason For Recall 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.

Event Detail

Event Id 62714
Product Type Devices
Status Terminated
Recalling Firm Sunquest Information Systems, Inc.
City Tucson
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-10-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
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