FDA recall record · openFDA
Siemens Healthcare Diagnostics Inc
89 FDA recalls on record (2023–2026) — 89 device. 89 still ongoing.
0
Class I (most serious)
89
Class II
0
Class III
89
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occu 8
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum 6
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The s 5
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 ( 4
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (Q 4
Recalls
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. Class II 2026-03-18 Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; Class II 2026-02-23 Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay Class II 2026-05-07 Atellica CH Urine Albumin (UAlb). Material Number: 11537225 Class II 2026-01-20 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; Class II 2026-04-02 RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. Class II 2025-06-26 epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. Class II 2025-07-07 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Class II 2025-06-04 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Class II 2025-06-04 Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; Class II 2025-10-06 Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Class II 2025-04-15 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa Class II 2025-03-19 ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Class II 2025-04-15 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci Class II 2025-10-06 Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. Class II 2025-03-11 IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; Class II 2025-10-06 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Class II 2025-06-04 Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. Class II 2025-03-31 Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog N Class II 2025-09-22 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. Class II 2025-08-11 Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; Class II 2025-05-22 ADVIA¿ 120/2120/2120i SETpoint Calibrator Class II 2025-06-04 epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Softw Class II 2025-03-19 Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an Class II 2024-07-26 Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; Class II 2024-11-12 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 Class II 2024-07-29 Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; Class II 2024-07-30 epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra Class II 2024-11-22 Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Class II 2024-05-17 epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra Class II 2024-11-22 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) Class II 2024-09-30 Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu Class II 2024-03-13 Atellica IM Erythropoietin (EPO) Assay (100 Test) Class II 2024-01-24 Atellica CI Analyzer. Catalog Numbers: 10947347. Class II 2024-11-04 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t Class II 2024-11-22 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151 Class II 2024-07-29 epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train Class II 2024-11-22 ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated Class II 2024-07-26 Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ Class II 2024-07-26 Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human Class II 2024-08-15 epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra Class II 2024-11-22 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Class II 2024-09-24 Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) Class II 2024-08-21 Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h Class II 2024-10-21 ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated Class II 2024-07-26 ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in Class II 2024-08-15 ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) Class II 2024-08-21 Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and Class II 2024-10-21 ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Class II 2024-01-24 epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by tra Class II 2024-11-22 epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by tra Class II 2024-11-22 epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by Class II 2024-11-22 Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated Class II 2024-07-26 IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody. Class II 2024-04-23 IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody. Class II 2024-04-23 DCA Systems HbA1c Reagent Kit Class II 2024-02-07 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Class II 2023-06-01 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu Class II 2023-07-25 Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in hum Class II 2023-01-27 Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran Class II 2023-07-10 Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human se Class II 2023-07-10 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to Class II 2023-10-26 epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX) Class II 2023-10-19 Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120 Class II 2023-03-16 Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human ser Class II 2023-01-27 Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum Class II 2023-01-09 Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum Class II 2023-01-27 RAPIDPOINT 500 Blood Gas System Class II 2023-09-26 Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human s Class II 2023-01-09 Aptio Automation Storage and Retrieval Module (SRM) Class II 2023-05-16 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) Class II 2023-08-08 Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic Class II 2023-04-05 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human se Class II 2023-07-10 ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Class II 2023-03-16 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to Class II 2023-10-26 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human seru Class II 2023-07-10 Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum a Class II 2023-01-27 RAPIDPOINT 500e Blood Gas System Class II 2023-09-26 ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), ac Class II 2023-04-05 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Class II 2023-06-01 ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum Class II 2023-01-09 Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimu Class II 2023-01-30 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to Class II 2023-10-26 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed t Class II 2023-10-26 Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum Class II 2023-01-09 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Class II 2023-12-15 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 Class II 2023-06-01 ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human Class II 2023-01-09 ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human seru Class II 2023-01-09
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.