Home / Recalls / Sekisui Diagnostics Llc / Z-0463-2013

Z-0463-2013 Class II Terminated

Recalled by Sekisui Diagnostics Llc — Stamford, CT

Recall Details

Product Type
Devices
Report Date
December 12, 2012
Initiation Date
October 24, 2012
Termination Date
January 8, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63 kits

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.

Distribution Pattern

Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.

Code Information

Lot # 120827, exp 11/27/2012

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