Siemens Healthcare Diagnostics

Reports per year

Source: FDA adverse event reports by year received, 2011–2025. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

• Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE548
• Immunoassay Method, Troponin SubunitMMI445
• Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhCHL409
• Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL192
• Automated Urinalysis SystemKQO172
• Electrode, Ion Specific, SodiumJGS86
• System, Hemoglobin, AutomatedGKR73
• Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ63
• System, Test, Human Chorionic GonadotropinDHA50
• Assay, Glycosylated HemoglobinLCP46

Recent recalls

• 2026-08-17Open, ClassifiedUnknown/Undetermined by firm

  Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

• 2026-08-17Open, ClassifiedUnknown/Undetermined by firm

  Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

  Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.

• 2026-08-14Open, ClassifiedUnder Investigation by firm

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

  Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

• 2026-08-14Open, ClassifiedUnder Investigation by firm

  Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

  Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

• 2026-08-05Open, ClassifiedUnder Investigation by firm

  Atellica CH Urine Albumin REF: 11537225

  processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

• 2026-08-04Open, ClassifiedUnder Investigation by firm

  Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

  Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

• 2026-08-04Open, ClassifiedUnder Investigation by firm

  Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

  out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

• 2026-07-08Open, ClassifiedUnder Investigation by firm

  Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

  The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

• 2026-06-10Open, ClassifiedUnder Investigation by firm

  Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

  A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

• 2026-04-29Open, ClassifiedUnder Investigation by firm

  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

  Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.