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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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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
Distribution Pattern Nationwide distribution

Product Detail

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