Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Presage ST2 Assay Recalled by Critical Diagnostics Due to The recall was initiated because Critical Diagnostics has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Critical Diagnostics directly.
Affected Products
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.
Quantity: 33 units
Why Was This Recalled?
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.
Where Was This Sold?
USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
About Critical Diagnostics
Critical Diagnostics has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report