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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

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

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.
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