FDA Enforcement
Class II
Terminated
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.
Recall: Z-2431-2012
·
Reported September 26, 2012
Enforcement
- Recall Number
- Z-2431-2012
- Event ID
- 63016
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Sekisui Diagnostics Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 26, 2012
- Initiation Date
- August 28, 2012
- Classification Date
- September 20, 2012
- Termination Date
- July 25, 2016
- Address
- 500 West Avenue, Stamford, CT, 06902, United States
Description
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.
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 Info
Lot Numbers: 120425 and 120601
Distribution
Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Quantity
699 kits