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All Recalls

Every Siemens Healthcare Diagnostics Recall

Sorted by most recent. Click any recall for full details.

19 recalls
High RiskFDA
Siemens Healthcare Diagnostics
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -00842768...
Diagnostic Devices·7,631 affected·Oct 17, 2017
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory envir...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environm...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 103...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 103132...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408,...
Diagnostic Devices·1,122 affected·Aug 6, 2014
High RiskFDA
Siemens Healthcare Diagnostics
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro...
Diagnostic Devices·5,953 affected·Dec 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare D...
Diagnostic Devices·892 affected·Dec 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF ...
Diagnostic Devices·1,191 affected·Sep 24, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·892 affected·Sep 3, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·625 affected·Sep 3, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IM...
Diagnostic Devices·2,201 affected·Aug 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tes...
Diagnostic Devices·4,695 affected·Aug 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter,...
Medical Devices·311 affected·Aug 12, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or uni...
Diagnostic Devices·1,546 affected·Jul 30, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the prin...
Medical Devices·950 affected·Jun 26, 2013
High RiskFDA
Siemens Healthcare Diagnostics
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/...
Diagnostic Devices·24,361 affected·Jun 26, 2013
RecallFDA
Siemens Healthcare Diagnostics
Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone...
Diagnostic Devices·742 affected·Nov 28, 2012
RecallFDA
Siemens Healthcare Diagnostics
Immunoradiometric assay.
Diagnostic Devices·831 affected·Nov 28, 2012