Recall Z-0463-2013 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Sekisui Diagnostics Llc
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.
| Date | Dec 3, 2012 (initiated Oct 24, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 63 kits |
| Distribution | Nationwide Distribution-including the states of FL, IN, NC, OH, UT, 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 |