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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Recall Number Z-0251-2013
Classification Class II
Code Info v3.0.0_07222004 and later
Product Distributed Qty 9 units
Reason For Recall The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.

Event Detail

Event Id 63380
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 2009-11-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.