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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
Recall Number Z-0732-2014
Classification Class II
Code Info All lots
Product Distributed Qty 395 units
Reason For Recall High positive calcium bias on plasma sample versus results on serum

Event Detail

Event Id 66202
Product Type Devices
Status Ongoing
Recalling Firm Vital Diagnostics, Inc.
City Lincoln
State RI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution