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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.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Diagnostic Devices·18,080 affected·Mar 18, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Medical Devices·21,291 affected·Feb 23, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Medical Devices·4,885 affected·Jan 20, 2026
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Medical Devices·28 affected·Oct 6, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control A...
Medical Devices·2,802 affected·Oct 6, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Medical Devices·34 affected·Oct 6, 2025
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Medical Devices·37,554 affected·Jul 7, 2025
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Medical Devices·1,477 affected·Jun 26, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Medical Devices·3,266 affected·Jun 4, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Medical Devices·3,435 affected·Jun 4, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Medical Devices·2,212 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Medical Devices·1,072 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sens...
Medical Devices·264,252 affected·Mar 19, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Medical Devices·0 affected·Mar 11, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·670 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·276 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical pr...
Diagnostic Devices·2,240 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical profes...
Diagnostic Devices·6,738 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·320 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Diagnostic Devices·13,115 affected·Nov 12, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.
Medical Devices·559 affected·Nov 4, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and pl...
Diagnostic Devices·11,330 affected·Oct 21, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Diagnostic Devices·7,332 affected·Sep 30, 2024
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Medical Devices·1,292 affected·Sep 24, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Diagnostic Devices·9,783 affected·Aug 21, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA C...
Diagnostic Devices·18,483 affected·Aug 15, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Diagnostic Devices·5,371 affected·Jul 30, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Medical Devices·1,164 affected·Jul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Medical Devices·143 affected·Jul 29, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
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 se...
Diagnostic Devices·0 affected·Jul 26, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
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 ...
Diagnostic Devices·0 affected·Jul 26, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
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 h...
Diagnostic Devices·0 affected·Jul 26, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
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...
Diagnostic Devices·0 affected·Jul 26, 2024
High RiskFDA
Siemens Healthcare Diagnostics Inc
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System...
Medical Devices·9 affected·May 17, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using ...
Medical Devices·8,721 affected·Mar 13, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Diagnostic Devices·1,057 affected·Jan 24, 2024
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,035 affected·Oct 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,611 affected·Oct 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW),...
Medical Devices·10,183 affected·Oct 19, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPOINT 500 Blood Gas System
Medical Devices·12,363 affected·Sep 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Diagnostic Devices·4,966 affected·Aug 8, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determ...
Diagnostic Devices·3,067 affected·Jul 25, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human ...
Diagnostic Devices·19,544 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (l...
Diagnostic Devices·18,524 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (l...
Diagnostic Devices·50,148 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lit...
Diagnostic Devices·6,733 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Medical Devices·473 affected·Jun 1, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Storage and Retrieval Module (SRM)
Medical Devices·83 affected·May 16, 2023