Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc.: 11 recalls listed since March 2026 across FDA.
By year
- 202611
By agency
- FDA11
By category
- Medical Device11
All recalls (11)
Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
Siemens Healthcare Diagnostics Beckman Coulter and Syva EMIT 2000 Quinidine Assay
The Syva EMIT 2000 Quinidine Assay has unacceptable precision, leading to erroneously elevated quinidine measurements.
2 products
Siemens Healthcare Diagnostics Atellica CH Urine Albumin
Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.
Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have out-of-specification sodium azide concentration, causing low health risk.
Syva Emit Disopyramide Assay Enzyme Immunoassay
The Syva Emit Disopyramide Assay has an out-of-specification sodium azide concentration, which can cause mild skin or eye irritation.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
The assay has a potential for intermittent well-to-well bias.
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Siemens Epoc BGEM BUN Test Cards
The affected product can result in discrepant low pH and measured Total Carbon Dioxide results.
Siemens Healthcare Diagnostics Dimension Creatinine Flex Reagent Cartridge
This imprecision may lead to erroneously decreased or increased creatinine patient results.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.
Atellica CH Urine Albumin (UAlb)
Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.
