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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Recall Number Z-0173-2014
Classification Class III
Code Info Kit Lot: 14136A16 04 Mar 2014
Product Distributed Qty 595 kits total (5 kits with packaging error)
Reason For Recall PTH Calibrator packaged with only high calibrator.

Event Detail

Event Id 66132
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 2013-08-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including MD, PA, and CT.