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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description ADVIA CentaurĀ® iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Recall Number Z-1512-2013
Classification Class II
Code Info Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
Product Distributed Qty 309 (100 test) kits
Reason For Recall iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Event Detail

Event Id 65224
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 2013-05-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.