Z-2431-2012 Class II Terminated
FDA device recall Z-2431-2012 was initiated by Sekisui Diagnostics Llc on August 28, 2012 and is designated Class II. Reason for recall: 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 di… The recall status is terminated (terminated July 25, 2016). Affected quantity: 699 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- August 28, 2012
- Termination Date
- July 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 699 kits
Product 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 for Recall
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.
Distribution Pattern
Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Code Information
Lot Numbers: 120425 and 120601