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U.S. Department of Health and Human Services

Class 3 Device Recall Presage ST2 Assay

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  Class 3 Device Recall Presage ST2 Assay see related information
Date Initiated by Firm February 28, 2012
Date Posted July 13, 2012
Recall Status1 Terminated 3 on July 16, 2012
Recall Number Z-2012-2012
Recall Event ID 62281
510(K)Number K111452  
Product Classification ST2 assay - Product Code OYG
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Critical Diagnostics
3030 Bunker Hill St Ste 115a
San Diego CA 92109-5754
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OYG and Original Applicant = CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
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