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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Recall Number Z-2229-2012
Classification Class III
Code Info Version 6.4.2
Product Distributed Qty 47 sites
Reason For Recall In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

Event Detail

Event Id 62452
Product Type Devices
Status Completed
Recalling Firm Sunquest Information Systems, Inc.
City Tucson
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution