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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Recall Number Z-0463-2013
Classification Class II
Code Info Lot # 120827, exp 11/27/2012
Product Distributed Qty 63 kits
Reason For Recall Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values with "0" standard reducing the slope of the standard curve requiring more frequent sample dilutions.

Event Detail

Event Id 63615
Product Type Devices
Status Ongoing
Recalling Firm Sekisui Diagnostics Llc
City Stamford
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.