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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
PMA Number: P930027
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IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN... 2 11/14/2024 Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Ki... 2 01/31/2017 Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Ki... 2 01/31/2017 Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Sie... 2 12/22/2016 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2... 2 12/22/2016 Siemens Healthcare Diagnostics, Inc.
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and... 2 08/23/2013 Siemens Healthcare Diagnostics
COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients... 2 09/16/2008 Siemens Medical Solutions Diagnostics
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