Device 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.
Z-0463-2013
Product summary
- Event
- Event 63615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 kits
- Official record key
device-enforcement:Z-0463-2013
Official wording
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.
Code information: Lot # 120827, exp 11/27/2012
Distribution pattern: Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
Derived failure modes
-
Unknown
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.