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U.S. Department of Health and Human Services

Class 2 Device Recall Sekisui Diagnostics, Spectrolyse PAI1 catalog 101201

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 Class 2 Recall
Sekisui Diagnostics, Spectrolyse PAI1 catalog 101201
see related information
Date Posted December 03, 2012
Recall Status1 Terminated on January 08, 2013
Recall Number Z-0463-2013
Recall Event ID 63615
Premarket Notification
510(K) Number
K063323 
Product Classification Test, Qualitative And Quantitative Factor Deficiency - Product Code GGP
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
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GGP and Original Applicant = AMERICAN DIAGNOSTICA, INC.
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