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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 Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Recall Number Z-1514-2013
Classification Class II
Code Info Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011
Product Distributed Qty 99 (2 pk)
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.