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Sekisui Diagnostics Llc recalls Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1
Recalled September 26, 2012 · FDA recall Z-2431-2012 · Sekisui Diagnostics
Hazard
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. · FDA Class II
Units
699 kits
Sold at
Nationwide distribution: USA including states of: FL, IN, IL, and WA.
Description
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.
Product
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.
Manufacturer(s)
Sekisui Diagnostics Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →