Presage ST2 Assay — Class III medical device recall Z-2012-2012
Terminated recall by Critical Diagnostics, reported 2012-07-25, distributed in CA. The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate t
| Recall number | Z-2012-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Critical Diagnostics, San Diego, CA, United States |
| Recall initiated | 2012-02-28 |
| Classified | 2012-07-13 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-07-16 |
| Distributed | CA |
| Countries outside the US | AT, ES, GB, IT |
| Quantity | 33 units |
| Reason classes | potency |
| Lot numbers | BC-1065E, RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3, RN-43116-4 |
| Model numbers | BC-1065, BC-1065E |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2012-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.