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Siemens Healthcare Diagnostics, Inc. Recalls

423 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Siemens Healthcare Diagnostics, Inc..

423Total Recalls
14Critical
15.1MUnits Affected
Mar 18, 2026Most Recent
All Recalls

Every Siemens Healthcare Diagnostics, Inc. Recall

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

423 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No...
Medical Devices·1,937 affected·Jan 10, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No...
Medical Devices·9,664 affected·Jan 10, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No...
Medical Devices·194 affected·Jan 10, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro ...
Diagnostic Devices·11,963 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic...
Diagnostic Devices·9,076 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic us...
Diagnostic Devices·1,148 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test ...
Diagnostic Devices·76,107 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in ...
Diagnostic Devices·1,379 affected·Dec 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurem...
Diagnostic Devices·11,165 affected·Dec 16, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (...
Diagnostic Devices·4,705 affected·Nov 18, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Medical Devices·23 affected·Oct 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·18,733 affected·Oct 19, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·30,222 affected·Oct 19, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumi...
Diabetes Devices·10,614 affected·Oct 7, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Diagnostic Devices·37,437 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Diagnostic Devices·69,781 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Modules
Medical Devices·448 affected·Sep 29, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calc...
Diabetes Devices·9,935 affected·Sep 15, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (...
Diagnostic Devices·5 affected·Aug 30, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista IRON Flex reagent cartridges
Diagnostic Devices·30,247 affected·Aug 25, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension IRON Flex reagent cartridges
Diagnostic Devices·38,230 affected·Aug 25, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 103...
Diagnostic Devices·177 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), U...
Diagnostic Devices·359 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320...
Medical Devices·2,910 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
Medical Devices·2,602 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Medical Devices·114 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
Medical Devices·6,786 affected·Aug 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Diagnostic Devices·0 affected·Aug 9, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myo...
Diagnostic Devices·2,248 affected·Aug 8, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Diagnostic Devices·5,991 affected·Aug 3, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) r...
Medical Devices·32 affected·Jul 20, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylli...
Diagnostic Devices·658 affected·Jun 17, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry s...
Diagnostic Devices·24,940 affected·May 5, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate A...
Diagnostic Devices·13,147 affected·May 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT Immunoassay System
Diagnostic Devices·292 affected·Apr 28, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial num...
Diagnostic Devices·1,301 affected·Mar 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial nu...
Diagnostic Devices·1,300 affected·Mar 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Triglycerides (TGL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Diabetes Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: ENZYMATIC CREATININE
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Triglycerides (TRIG)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Uric Acid (URCA)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-q...
Diagnostic Devices·8 affected·Mar 10, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measur...
Diagnostic Devices·7,433 affected·Mar 7, 2016