FDA Enforcement
Class II
Terminated
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.
Recall: Z-0463-2013
·
Reported December 12, 2012
Enforcement
- Recall Number
- Z-0463-2013
- Event ID
- 63615
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Sekisui Diagnostics Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 12, 2012
- Initiation Date
- October 24, 2012
- Classification Date
- December 3, 2012
- Termination Date
- January 8, 2013
- Address
- 500 West Avenue, N/A, Stamford, CT, 06902, United States
Description
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.
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 Info
Lot # 120827, exp 11/27/2012
Distribution
Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
Quantity
63 kits