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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
PMA Number: P930027
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IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Ki... 2 Jan-31-2017 Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Ki... 2 Jan-31-2017 Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Sie... 2 Dec-22-2016 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2... 2 Dec-22-2016 Siemens Healthcare Diagnostics, Inc.
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and... 2 Aug-23-2013 Siemens Healthcare Diagnostics
COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients... 2 Sep-16-2008 Siemens Medical Solutions Diagnostics
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