Siemens Healthcare Diagnostics, Inc. recalls

All Siemens Healthcare Diagnostics, Inc. recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (45).

45 recalls published between October 9, 2024 and August 26, 2026. Most common issues: software (9), undeclared allergen (3), laceration (2), microbial contamination (1).

• Beckman Coulter, Emit 2000 Quinidine Assay recall
  FDA August 26, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Syva EMIT 2000 Quinidine Assay recall
  FDA August 26, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Urine Albumin recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN… recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 recall
  FDA August 12, 2026 · Siemens Healthcare Diagnostics, Inc. · Class III
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall
  FDA July 15, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recall
  FDA June 17, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall
  FDA May 6, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Dimension Creatinine Flex reagent cartridge recall
  FDA May 6, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall
  FDA April 8, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Urine Albumin (UAlb) recall
  FDA March 11, 2026 · Siemens Healthcare Diagnostics, Inc. · Class II
• Food Panel 3 Specific Allergen recall
  FDA November 19, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• 3gAllergy Specific IgE Universal Kit recall
  FDA November 19, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• IMMULITE 2000 Oak Mix Specific Allergen recall
  FDA November 19, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Assay: IMMULITE 2000 Intact PTH recall
  FDA November 5, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) recall
  FDA September 17, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc BGEM BUN Test Card [25pk]. Material Number: 10736515 recall
  FDA August 13, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack) recall
  FDA August 6, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) recall
  FDA July 9, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) recall
  FDA July 9, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) recall
  FDA July 9, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA¿ 120/2120/2120i SETpoint Calibrator recall
  FDA July 9, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Diluent - CONS 2 x 1.5L recall
  FDA July 2, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA Centaur HCY Calibrator (2 Pack) recall
  FDA June 4, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica IM Homocysteine Calibrator (2 Pack) recall
  FDA June 4, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System recall
  FDA May 7, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall
  FDA May 7, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in… recall
  FDA May 7, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CH Revised C Reactive Protein (RCRP) recall
  FDA April 16, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Magnesium Flex reagent cartridge, 360 tests recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc NXS Host recall
  FDA January 1, 2025 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the… recall
  FDA December 11, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica CI Analyzer recall
  FDA December 11, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that… recall
  FDA November 27, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• IMMULITE 2000 PSA assay recall
  FDA November 20, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System… recall
  FDA November 13, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467… recall
  FDA October 9, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II
• ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887… recall
  FDA October 9, 2024 · Siemens Healthcare Diagnostics, Inc. · Class II