Brand

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 Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibratin...
Diagnostic Devices·6,546 affected·Apr 5, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro d...
Diagnostic Devices·34,746 affected·Mar 16, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol...
Diagnostic Devices·18,961 affected·Mar 16, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plas...
Diagnostic Devices·11,824 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (li...
Diagnostic Devices·8,420 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithi...
Diagnostic Devices·13,071 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithiu...
Diagnostic Devices·5,315 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cel...
Diagnostic Devices·13,843 affected·Jan 9, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red bloo...
Diagnostic Devices·1,865 affected·Jan 9, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies...
Diagnostic Devices·158 affected·Dec 22, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 e...
Medical Devices·22,156 affected·Dec 12, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi...
Diagnostic Devices·717 affected·Dec 7, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative...
Medical Devices·560 affected·Nov 4, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diag...
Diagnostic Devices·1,000 affected·Nov 4, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Diagnostic Devices·586 affected·Sep 19, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Medical Devices·373 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Medical Devices·10,201 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalo...
Diagnostic Devices·1,592 affected·Aug 24, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material...
Diagnostic Devices·129 affected·Jul 18, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin...
Diagnostic Devices·1,614 affected·Jun 28, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagu...
Diagnostic Devices·263 affected·Jun 1, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma...
Cardiac Devices·76 affected·May 18, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma ...
Cardiac Devices·113 affected·May 18, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens...
Diagnostic Devices·1,566 affected·Apr 13, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens ...
Diagnostic Devices·2,321 affected·Apr 13, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Diagnostic Devices·952 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All ...
Diagnostic Devices·88 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 Al...
Diagnostic Devices·230 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Diagnostic Devices·374 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog n...
Medical Devices·10,755 affected·Feb 22, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Medical Devices·199 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Medical Devices·2,158 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Medical Devices·6,606 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. ...
Diagnostic Devices·14,220 affected·Jan 28, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human s...
Diagnostic Devices·46 affected·Dec 1, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,326 affected·Oct 15, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,407 affected·Oct 15, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 1...
Medical Devices·1,142 affected·Oct 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM 1600 Analyzer, SMN 11066000
Medical Devices·1,733 affected·Sep 28, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Diagnostic Devices·261 affected·Sep 22, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Diagnostic Devices·149 affected·Sep 22, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Medical Devices·246 affected·Sep 20, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29...
Diagnostic Devices·437 affected·Jul 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer anti...
Diagnostic Devices·787 affected·Jul 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs ...
Diagnostic Devices·842 affected·May 18, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Diagnostic Devices·233 affected·May 13, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Medical Devices·2,153 affected·May 4, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to T...
Diagnostic Devices·22,550 affected·Apr 21, 2021