FDA Class II · Medical device · October 7, 2026
Atellica CH Revised C-Reactive Protein (RCRP) recall — Siemens Healthcare Diagnostics, Inc.
The potential for falsely elevated results.
Official ID Z-3335-2026 · Official record ↗
Siemens Healthcare Diagnostics recalls
10 recent recalls on record for Siemens Healthcare Diagnostics in connected official government data as of October 22, 2026 at 12:00 PM UTC.
Models with recalls
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) (1)Atellica CH Revised C-Reactive Protein (RCRP) (1)Atellica CH Urine Albumin REF (1)Beckman Coulter (1)Dimension Creatinine Flex reagent cartridge (1)Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) (1)Syva EMIT 2000 Quinidine Assay REF (1)Syva Emit Disopyramide Assay Enzyme Immunoassay (1)Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No (1)epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System (1)
All Siemens Healthcare Diagnostics recalls
FDA Class II · Medical device · August 26, 2026
Beckman Coulter recall — Siemens Healthcare Diagnostics, Inc.
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 o…
Official ID Z-2976-2026 · Official record ↗
FDA Class II · Medical device · August 26, 2026
Syva EMIT 2000 Quinidine Assay REF recall — Siemens Healthcare Diagnostics, Inc.
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 o…
Official ID Z-2975-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Atellica CH Urine Albumin REF recall — Siemens Healthcare Diagnostics, Inc.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH En…
Official ID Z-2890-2026 · Official record ↗
FDA Class III · Medical device · August 12, 2026
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No recall — Siemens Healthcare Diagnostics, Inc.
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 h…
Official ID Z-2881-2026 · Official record ↗
FDA Class III · Medical device · August 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay recall — Siemens Healthcare Diagnostics, Inc.
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 t…
Official ID Z-2880-2026 · Official record ↗
FDA Class II · Medical device · July 15, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) recall — Siemens Healthcare Diagnostics, Inc.
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 patien…
Official ID Z-2703-2026 · Official record ↗
FDA Class II · Medical device · June 17, 2026
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recall — Siemens Healthcare Diagnostics, Inc.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Official ID Z-2398-2026 · Official record ↗
FDA Class II · Medical device · May 6, 2026
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall — Siemens Healthcare Diagnostics Inc
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…
Official ID Z-2005-2026 · Official record ↗
FDA Class II · Medical device · May 6, 2026
Dimension Creatinine Flex reagent cartridge recall — Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quali…
Official ID Z-1980-2026 · Official record ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.