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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Kit Lot: 14136A16 04 Mar 2014 Class III PTH Calibrator packaged with only high calibrator. 595 kits total (5 kits with packaging error) Z-0173-2014
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