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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GGP
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