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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 66267
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City Newark
State DE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Mexico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380. Class II Imprecision with certain lots 4963 Z-0181-2014
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