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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
Related Medical Device Recalls Date Classified to: 08/01/2014
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Z-1928-2012 - Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood a... 1 Jul-06-2012 Alere San Diego, Inc.
Z-1929-2012 - Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. 1 Jul-06-2012 Alere San Diego, Inc.
Z-1932-2012 - Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. 1 Jul-06-2012 Alere San Diego, Inc.
Z-1931-2012 - Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). 1 Jul-06-2012 Alere San Diego, Inc.
Z-1930-2012 - Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing... 1 Jul-06-2012 Alere San Diego, Inc.
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