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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description 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 immunosorbant 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
Classification Class III
Code Info 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.
Product Distributed Qty 33 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.

Event Detail

Event Id 62281
Product Type Devices
Status Terminated
Recalling Firm Critical Diagnostics
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-28
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.