Siemens Healthcare Diagnostics, Inc.

Complete recall history across all FDA and CPSC categories — 452 total recalls

Siemens Healthcare Diagnostics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (452)

FDA medical device enforcement actions by Siemens Healthcare Diagnostics, Inc.. Showing most recent 50.

Date Product Reason Class
Jan 20, 2026 Atellica CH Urine Albumin (UAlb). Material Number: 11537225 Falsely depressed UAlb patient results may occur. Affected samples with any ... Class II
Oct 6, 2025 IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038... The barcode orientation on affected devices causes incorrect scanning order o... Class II
Oct 6, 2025 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE ... The barcode orientation on affected devices causes incorrect scanning order o... Class II
Oct 6, 2025 Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Ca... The barcode orientation on affected devices causes incorrect scanning order o... Class II
Sep 22, 2025 Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (S... The potential for falsely depressed Intact PTH patient results at the low end... Class II
Aug 11, 2025 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109... Potential for falsely depressed patient, quality control (QC), and/or calibra... Class II
Jun 4, 2025 ADVIA¿ 120/2120/2120i SETpoint Calibrator Products have the incorrect platelet (PLT) value assignments for the ADVIA 12... Class II
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 12... Class II
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 12... Class II
Jun 4, 2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Products have the incorrect platelet (PLT) value assignments for the ADVIA 12... Class II
May 22, 2025 Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact ... Class II
Apr 15, 2025 ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Cal... Class II
Apr 15, 2025 Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Cal... Class II
Mar 11, 2025 Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... Incorrect software flagging may occur for the assay that may potentially lead... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System ... Class II
Nov 12, 2024 Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens M... Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista... Class II
Nov 4, 2024 Atellica CI Analyzer. Catalog Numbers: 10947347. Potential that the IMT Diluent volume remaining (% remaining) does not decrea... Class II
Oct 21, 2024 Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with... Class II
Oct 21, 2024 Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantita... Potential for falsely depressed auto-diluted results for samples above the m... Class II
Sep 30, 2024 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog... The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XP... Class II
Aug 21, 2024 ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... Positive bias in patient results at and below the cut-off of 60 U/mL with the... Class II
Aug 21, 2024 Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... Positive bias in patient results at and below the cut-off of 60 U/mL with the... Class II
Aug 15, 2024 ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿... Class II
Aug 15, 2024 Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿... Class II
Jul 30, 2024 Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Mater... During manufacturing, the last three tests from the 160 test flex of lot 2320... Class II
Jul 29, 2024 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material ... The potential for biased quality control (QC) and patient results when using... Class II
Jul 29, 2024 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Numb... The potential for biased quality control (QC) and patient results when using... Class II
Jul 26, 2024 Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative m... Positive bias for some samples around the CA 19-9 upper limit of normal of 35... Class II
Jul 26, 2024 ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative ... Positive bias for some samples around the CA 19-9 upper limit of normal of 35... Class II
Jul 26, 2024 Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitat... Positive bias for some samples around the CA 19-9 upper limit of normal of 35... Class II
Jul 26, 2024 ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative m... Positive bias for some samples around the CA 19-9 upper limit of normal of 35... Class II
Jul 26, 2024 Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative mea... Positive bias for some samples around the CA 19-9 upper limit of normal of 35... Class II
Apr 23, 2024 IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System... The potential for falsely elevated patient sample results when using impacted... Class II
Apr 23, 2024 IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System... The potential for falsely elevated patient sample results when using impacted... Class II
Mar 13, 2024 Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atelli... Class II
Feb 7, 2024 DCA Systems HbA1c Reagent Kit The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confi... Class II
Jan 24, 2024 ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35%... Class II
Jan 24, 2024 Atellica IM Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35%... Class II
Dec 15, 2023 Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Potential for a negative bias with quality control (QC) and patient sample re... Class II
Aug 8, 2023 ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... There is a potential for a positive bias on Quality Control (QC) and patient ... Class II
Jul 25, 2023 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 1... There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein ... Class II
Jul 10, 2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... Potential for reagent carryover on the Atellica CH 930 resulting in a positiv... Class II
Jul 10, 2023 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positiv... Class II

View all 452 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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