Sekisui Diagnostics Llc recalls Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activa

Recalled December 12, 2012 · FDA recall Z-0463-2013 · Sekisui Diagnostics

Hazard

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. · FDA Class II

Units

63 kits

Sold at

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

Description

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.

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.

Manufacturer(s)

Sekisui Diagnostics Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →