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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Sekisui Diagnostics, Spectrolyse PAI-1 catalog # 101201		see related information
Date Posted December 03, 2012
Recall Number Z-0463-2013
Product 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.
Code Information Lot # 120827, exp 11/27/2012
Recalling Firm/
Manufacturer		 Sekisui Diagnostics Llc
500 West Avenue
Stamford, Connecticut 06902
Reason for
Recall		 Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Action Sekisui Diagnostics issued an "URGENT PRODUCT RECALL NOTICE" dated October 24, 2012 to all consignees. The letter instructed consignees to immediately stop using the specified lot of product, discard any remaining inventory and return the enclosed response form. Contact the Customer Service Department at 800-637-3375, ext. 10, 12, or 31 for assistance with this recall.
Quantity in Commerce 63 kits
Distribution Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
 
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