Device 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.
Z-2431-2012
Product summary
- Event
- Event 63016
- Status
- Terminated
- Classification
- Class II
- Quantity
- 699 kits
- Official record key
device-enforcement:Z-2431-2012
Official wording
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.
Code information: Lot Numbers: 120425 and 120601
Distribution pattern: Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Derived failure modes
-
Unknown
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.