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.
FDA Recall Z-2012-2012 · Posted 2012-07-13
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Recalling FirmCritical Diagnostics
Recall StatusTerminated
Product CodeOYG
Date Initiated2012-02-28
Date Terminated2012-07-16
Product Quantity33 units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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