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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.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an au...
Diagnostic Devices·1,528 affected·Oct 11, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer
Medical Devices·1,432 affected·Sep 23, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Medical Devices·88 affected·Aug 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Medical Devices·166 affected·Aug 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ ...
Diagnostic Devices·169 affected·Aug 14, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Diagnostic Devices·12,796 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Diagnostic Devices·10,928 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Diagnostic Devices·3,627 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on ...
Diagnostic Devices·815 affected·Jul 15, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Medical Devices·4,780 affected·Jul 10, 2019
High RiskFDA
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in...
Cardiac Devices·2,312 affected·May 29, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry C...
Diagnostic Devices·3,386 affected·May 3, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, Material Number 11066000
Medical Devices·366 affected·Mar 7, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Diagnostic Devices·10,414 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Diagnostic Devices·1,489 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
Diagnostic Devices·114 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipettin...
Diagnostic Devices·1,649 affected·Oct 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetti...
Diagnostic Devices·1,628 affected·Oct 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lacta...
Diagnostic Devices·13,435 affected·Oct 11, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿...
Medical Devices·277 affected·Sep 28, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: Th...
Diagnostic Devices·490 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The...
Diagnostic Devices·217 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component...
Diagnostic Devices·264 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro ...
Diagnostic Devices·3,956 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic t...
Diagnostic Devices·18,396 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO 15000 REFRIGERATED STORAGE MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO RACK INPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB CORE UNIT / LYNX WITH IOM
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO INPUT/OUTPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO RACK OUTPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assa...
Diagnostic Devices·97 affected·Jul 24, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB ...
Diagnostic Devices·1,870 affected·Jul 24, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centau...
Diagnostic Devices·2 affected·Jul 24, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing ...
Diabetes Devices·2,357 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing t...
Diabetes Devices·138 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality...
Diabetes Devices·10,199 affected·Jul 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·107 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·92 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing ...
Diagnostic Devices·5 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·35 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·115 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinic...
Diagnostic Devices·45 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Diagnostic Devices·7,543 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, ...
Diagnostic Devices·20,373 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Diagnostic Devices·0 affected·Mar 27, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Medical Devices·1,195 affected·Mar 21, 2018