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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Product Detail

Product Description Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Recall Number Z-0073-2013
Classification Class III
Code Info Versions 6.4.0 and later
Product Distributed Qty 127 sites
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.

Event Detail

Event Id 62516
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 2011-11-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution
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