Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Nov 19, 2025
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
FDA Devices Moderate Nov 19, 2025
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2U…
FDA Devices Moderate Nov 19, 2025
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
FDA Devices Moderate Aug 13, 2025
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Devices Moderate Aug 6, 2025
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
FDA Devices Moderate Jul 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
FDA Devices Moderate Jul 9, 2025
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Devices Moderate Jun 4, 2025
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
FDA Devices Moderate Jun 4, 2025
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
FDA Devices Moderate May 7, 2025
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configura…
FDA Devices Moderate Apr 16, 2025
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
FDA Devices Moderate Jan 1, 2025
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals …
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as a…
FDA Devices Moderate Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
FDA Devices Moderate Dec 11, 2024
Atellica CI Analyzer. Catalog Numbers: 10947347.
FDA Devices Moderate Dec 11, 2024
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Sieme…
FDA Devices Moderate Nov 20, 2024
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
FDA Devices Moderate Nov 13, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Devices Moderate Oct 9, 2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
FDA Devices Moderate Sep 25, 2024
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry sys…
FDA Devices Moderate Sep 25, 2024
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistr…
FDA Devices Moderate Sep 18, 2024
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using th…
FDA Devices Moderate Sep 18, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
FDA Devices Moderate Sep 18, 2024
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
FDA Devices Moderate Sep 18, 2024
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
FDA Devices Moderate Sep 18, 2024
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using …
FDA Devices Moderate Sep 18, 2024
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum u…
FDA Devices Moderate Sep 18, 2024
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using…
FDA Devices Moderate Jul 3, 2024
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 114…
FDA Devices Moderate Apr 24, 2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica…
FDA Devices Moderate Mar 20, 2024
Atellica IM Erythropoietin (EPO) Assay (100 Test)
FDA Devices Moderate Dec 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in …
FDA Devices Moderate Dec 27, 2023
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (J…
FDA Devices Moderate Dec 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in …
FDA Devices Moderate Dec 6, 2023
RAPIDPOINT 500 Blood Gas System
FDA Devices Moderate Dec 6, 2023
RAPIDPOINT 500e Blood Gas System
FDA Devices Moderate Oct 11, 2023
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
FDA Devices Moderate Sep 6, 2023
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Devices Moderate Sep 6, 2023
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium …
FDA Devices Moderate Sep 6, 2023
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and pl…
FDA Devices Moderate Sep 6, 2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium hepa…
FDA Devices Moderate Sep 6, 2023
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium hepari…
FDA Devices Moderate Sep 6, 2023
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) …
FDA Devices Moderate Sep 6, 2023
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium hepar…
FDA Devices Moderate Sep 6, 2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium hepari…
FDA Devices Moderate Sep 6, 2023
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, s…
FDA Devices Moderate Aug 30, 2023