Z-2012-2012Class III

Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an...

Name: Z-2012-2012 Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an...
Creator: Critical Diagnostics
Published: 2012-02-28
License: https://open.fda.gov/license/

Critical Diagnostics / initiated 2012-02-28 / Terminated / root cause: design

FDA source

Critical Diagnostics began a recall of 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... on 2012-02-28. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2012-2012
Classification: Class III
Status: Terminated
Initiated: 2012-02-28
Posted: 2012-07-13
Terminated: 2012-07-16
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.
Product code: OYG St2 Assay
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.
Root cause tag: design
FDA 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 in commerce: 33 units
Distribution: USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2012-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2012-2012	Class III	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-13

Product code OYG

K111452Class IIPresage St2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag / cleared 2011-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)