Siemens Healthcare Diagnostics recalls

Siemens Healthcare Diagnostics appears in 695 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Atellica CH Revised C-Reactive Protein (RCRP)
  FDA Device · Class II · 2026-10-07 · Siemens Healthcare Diagnostics
• Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
  FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics
• Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
  FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics
• Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
  FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics
• Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
  FDA Device · Class II · 2026-08-12 · Siemens Healthcare Diagnostics
• Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
  FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536
  FDA Device · Class II · 2026-07-15 · Siemens Healthcare Diagnostics
• Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795
  FDA Device · Class II · 2026-06-17 · Siemens Healthcare Diagnostics
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
  FDA Device · Class II · 2026-05-06 · Siemens Healthcare Diagnostics
• Dimension Creatinine Flex reagent cartridge
  FDA Device · Class II · 2026-05-06 · Siemens Healthcare Diagnostics
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
  FDA Device · Class II · 2026-04-08 · Siemens Healthcare Diagnostics
• Atellica CH Urine Albumin (UAlb)
  FDA Device · Class II · 2026-03-11 · Siemens Healthcare Diagnostics
• Food Panel 3 Specific Allergen
  FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics
• IMMULITE 2000 Oak Mix Specific Allergen
  FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics
• 3gAllergy Specific IgE Universal Kit
  FDA Device · Class II · 2025-11-19 · Siemens Healthcare Diagnostics
• Assay: IMMULITE 2000 Intact PTH
  FDA Device · Class II · 2025-11-05 · Siemens Healthcare Diagnostics
• Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543
  FDA Device · Class II · 2025-09-17 · Siemens Healthcare Diagnostics
• epoc BGEM BUN Test Card [25pk]. Material Number: 10736515
  FDA Device · Class II · 2025-08-13 · Siemens Healthcare Diagnostics
• RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
  FDA Device · Class II · 2025-08-06 · Siemens Healthcare Diagnostics
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
  FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
  FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
  FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics
• ADVIA¿ 120/2120/2120i SETpoint Calibrator
  FDA Device · Class II · 2025-07-09 · Siemens Healthcare Diagnostics
• Product: Atellica CH Diluent - CONS 2 x 1.5L
  FDA Device · Class II · 2025-07-02 · Siemens Healthcare Diagnostics
• ADVIA Centaur HCY Calibrator (2 Pack)
  FDA Device · Class II · 2025-06-04 · Siemens Healthcare Diagnostics
• Atellica IM Homocysteine Calibrator (2 Pack)
  FDA Device · Class II · 2025-06-04 · Siemens Healthcare Diagnostics
• Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma
  FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics
• epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System
  FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
  FDA Device · Class II · 2025-05-07 · Siemens Healthcare Diagnostics
• Atellica CH Revised C Reactive Protein (RCRP)
  FDA Device · Class II · 2025-04-16 · Siemens Healthcare Diagnostics
• Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• epoc NXS Host
  FDA Device · Class II · 2025-01-01 · Siemens Healthcare Diagnostics
• Atellica CI Analyzer
  FDA Device · Class II · 2024-12-11 · Siemens Healthcare Diagnostics
• Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plas…
  FDA Device · Class II · 2024-12-11 · Siemens Healthcare Diagnostics
• Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to ea…
  FDA Device · Class II · 2024-11-27 · Siemens Healthcare Diagnostics
• IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
  FDA Device · Class II · 2024-11-20 · Siemens Healthcare Diagnostics
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
  FDA Device · Class II · 2024-11-13 · Siemens Healthcare Diagnostics
• ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
  FDA Device · Class II · 2024-10-09 · Siemens Healthcare Diagnostics
• Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
  FDA Device · Class II · 2024-10-09 · Siemens Healthcare Diagnostics
• Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Che…
  FDA Device · Class II · 2024-09-25 · Siemens Healthcare Diagnostics
• ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVI…
  FDA Device · Class II · 2024-09-25 · Siemens Healthcare Diagnostics
• 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 hum…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• 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 se…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics