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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67930
Product Type Devices
Status Terminated
Recalling Firm Siemens Healthcare Diagnostics Inc
City Norwood
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution in the state of: CA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. Serial Number: 212809 Class III Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. 1 unit Z-1545-2014