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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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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
Distribution Pattern Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot # 120827, exp 11/27/2012 Class II 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. 63 kits Z-0463-2013