Recall Z-0463-2013— Sekisui Diagnostics Llc
Class II · Terminated
Class II FDA medical device recall by Sekisui Diagnostics Llc, initiated 2012-10-24, terminated 2013-01-08. It names one FDA 510(k) clearance: K063323. 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.. 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..
- Recalling firm
- Sekisui Diagnostics Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-24
- Terminated
- 2013-01-08
- Firm location
- Stamford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.