FDA Medical Device Recalls (openFDA)
Critical Diagnostics: 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.
- Recall number
- Z-2012-2012
- Recalling firm
- Critical Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2012-02-28
- Posted
- 2012-07-13
- Terminated
- 2012-07-16
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- Critical Diagnostics sent a Medical Device Recall letter dated March 5, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were instructed to please use Federal Express (FedEx) to return the kits, and charge to account: 305599069 Replacement kits will be sent to you. Customers with questions about this notice were instructed to contact Critical Diagnostics' customer support at (877) 700-1250 ext 3.
- Quantity
- 33 units
- Distribution
- USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
- Lot, serial or model codes
- BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.
- 510(k) numbers
- ["K111452"]
- PMA numbers
- not on file
- Product code
- OYG
- Firm FEI
- 3008661376
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28