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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
Recall Number Z-1121-2013
Classification Class II
Code Info Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013
Product Distributed Qty 372 pk Cals
Reason For Recall Negative bias in patient samples for Vitamin D

Event Detail

Event Id 64610
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc
City East Walpole
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.