Recall Z-2431-2012 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Sekisui Diagnostics Llc
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.
| Date | Sep 20, 2012 (initiated Aug 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 kit |
| Quantity | 699 kits |
| Distribution | Nationwide distribution: USA including states of: FL, IN, IL, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 American Diagnostica, Inc., Aug 15, 2007 |