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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
Recall Number Z-1410-2014
Classification Class II
Code Info Catalog number: 75002, All lots
Product Distributed Qty ALL
Reason For Recall Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Event Detail

Event Id 67665
Product Type Devices
Status Ongoing
Recalling Firm LumiQuick Diagnostics Inc.
City Santa Clara
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of CA, FL, NJ, TX, and NY.