Critical Diagnostics: Medical Device Recalls in 2012

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Critical Diagnostics in 2012. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

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.