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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 Versions 6.4 and later using Microbiology Result Entry
Recall Number Z-2270-2012
Classification Class II
Code Info Versions 6.4 and later
Product Distributed Qty 127 sites
Reason For Recall The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

Event Detail

Event Id 62708
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 2011-12-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA (nationwide) and the country of Canada.