Critical Diagnostics Recalls Presage ST2 Assay Kits Due to Inaccurate Results
Critical Diagnostics is recalling Presage ST2 Assay kits because they may produce inaccurate test results for patients with chronic heart failure.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to inaccurate diagnostic data rather than direct physical injury.
Plain-English summary
Critical Diagnostics is recalling 33 units of the Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. This in vitro diagnostic device is used to measure ST2 levels in serum or plasma to help assess the prognosis of patients diagnosed with chronic heart failure.
The recall was initiated because the manufacturer confirmed that it is possible to obtain inaccurate test results when using these specific kits. The affected lots include Lot No. RN-43116-4 for US distribution and Lots RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, and RN-43116-3 for European distribution.
The products were distributed in the United States, including California, as well as in Austria, Spain, the United Kingdom, and Italy. Users of these kits should stop using the affected lots and contact Critical Diagnostics for further instructions.
The recalled product
- 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…
- Manufacturer
- Critical Diagnostics
- Hazard
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- RN-42467-2
- RN-43116-1
- RN-43116-2
- RN-43116-3.
Distribution
Distributed in 1 state:
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