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U.S. Department of Health and Human Services

Class 2 Device Recall Spectrolyse PAI1

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  Class 2 Device Recall Spectrolyse PAI1 see related information
Date Initiated by Firm August 28, 2012
Date Posted September 20, 2012
Recall Status1 Terminated 3 on July 25, 2016
Recall Number Z-2431-2012
Recall Event ID 63016
510(K)Number K063323  
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
Product Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma.
Catalog Number: 101201

For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Code Information Lot Numbers: 120425 and 120601
Recalling Firm/
Manufacturer		 Sekisui Diagnostics Llc
500 West Avenue
Stamford CT 06902
Manufacturer Reason
for Recall		 SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
FDA Determined
Cause 2		 Process control
Action The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.
Quantity in Commerce 699 kits
Distribution Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GGP and Original Applicant = AMERICAN DIAGNOSTICA, INC.
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