Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
This page shows every FDA and USDA recall linked to Siemens Healthcare Diagnostics, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
224
Total Recalls
2012
First Recall
2026
Most Recent
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Mar 2, 2026
· Device
Open, Classified
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Sep 8, 2025
· Device
Open, Classified
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Jul 3, 2025
· Device
Open, Classified
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Jul 3, 2025
· Device
Open, Classified
ADVIA 120/2120/2120i SETpoint Calibrator
Jul 3, 2025
· Device
Open, Classified
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Jul 3, 2025
· Device
Open, Classified
Product: Atellica CH Diluent - CONS 2 x 1.5L;
Siemens Material Number (SMN): 11099300;
Jun 25, 2025
· Device
Open, Classified
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Apr 10, 2025
· Device
Open, Classified
Atellica CI Analyzer. Catalog Numbers: 10947347.
Dec 4, 2024
· Device
Open, Classified
Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobul...
Dec 4, 2024
· Device
Open, Classified
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction v...
Nov 20, 2024
· Device
Open, Classified
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Sep 27, 2024
· Device
Open, Classified
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Sep 27, 2024
· Device
Open, Classified
Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin...
Sep 18, 2024
· Device
Open, Classified
ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microal...
Sep 18, 2024
· Device
Open, Classified
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Sep 6, 2024
· Device
Open, Classified
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Sep 6, 2024
· Device
Open, Classified
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin...
Apr 16, 2024
· Device
Open, Classified
DCA Systems HbA1c Reagent Kit
Mar 19, 2024
· Device
Open, Classified
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Mar 11, 2024
· Device
Open, Classified
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Mar 11, 2024
· Device
Open, Classified
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Feb 7, 2024
· Device
Open, Classified
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 test...
Sep 30, 2023
· Device
Open, Classified
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in hu...
Aug 29, 2023
· Device
Open, Classified
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in...
Aug 29, 2023
· Device
Open, Classified
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use
in the quantitative measurement of triglyceri...
Aug 29, 2023
· Device
Open, Classified
Atellica CH Triglycerides_2: in vitro diagnostic use in the
quantitative determination of triglycerides in hum...
Aug 29, 2023
· Device
Open, Classified
Atellica CH HDL Cholesterol- In vitro diagnostic use in the
quantitative determination of HDL cholesterol in...
Aug 28, 2023
· Device
Open, Classified
Atellica CH LDL Cholesterol- In vitro diagnostic use in the
quantitative determination of LDL cholesterol in h...
Aug 28, 2023
· Device
Open, Classified
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glu...
Aug 28, 2023
· Device
Open, Classified
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the
quantitative determination of total bilirubin in...
Aug 28, 2023
· Device
Open, Classified
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use...
Aug 24, 2023
· Device
Open, Classified
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia...
May 25, 2023
· Device
Open, Classified
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro di...
May 25, 2023
· Device
Open, Classified
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926),...
May 3, 2023
· Device
Open, Classified
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material N...
May 3, 2023
· Device
Open, Classified
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of...
Mar 15, 2023
· Device
Open, Classified
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMUL...
Jan 11, 2023
· Device
Open, Classified
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for...
Jan 11, 2023
· Device
Open, Classified
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Oct 20, 2022
· Device
Open, Classified
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Oct 20, 2022
· Device
Open, Classified
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative
determination of iron in human...
Jun 28, 2022
· Device
Open, Classified
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on c...
Apr 13, 2022
· Device
Open, Classified
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on c...
Apr 13, 2022
· Device
Open, Classified
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material...
Feb 22, 2022
· Device
Open, Classified
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Feb 9, 2022
· Device
Open, Classified
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Feb 9, 2022
· Device
Open, Classified
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Feb 9, 2022
· Device
Open, Classified
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Feb 9, 2022
· Device
Open, Classified
Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2...
Dec 1, 2021
· Device
Terminated