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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

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

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 Visit
Distribution Pattern US Distribution in the state of: CA.