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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64112
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. d.b.a. Mindray North America
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in the states of NC and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BS-200 Chemistry Analyzer Designed for clinical laboratory use. Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F. Class II An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. 3 units Z-0977-2013