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Critical Diagnostics recalls Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitr
Recalled July 25, 2012 · FDA recall Z-2012-2012 · Critical Diagnostics
Hazard
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits. · FDA Class III
Units
33 units
Sold at
USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
Description
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Product
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Manufacturer(s)
Critical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →