FDA•MODERATE
Syva EMIT 2000 Quinidine Assay
Siemens recalls Syva EMIT 2000 Quinidine Assay over precision issues that may cause elevated readings and risk of cardiac arrhythmias.
2 productsSiemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc.: 9 recalls listed since March 2026 across FDA.
By year
- 20269
By agency
- FDA9
By category
- Medical Device9
All recalls (9)
FDA•MODERATEAtellica CH Urine Albumin AssaySiemens recalls Atellica CH Urine Albumin assay over falsely depressed UN_c and A1c_E results and QC failures.
2 products- FDA•LOWSyva Emit Disopyramide Assay
Siemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.
FDA•LOWSyva Emit Tox Tricyclic Antidepressant Calibrator/ControlsSiemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
FDA•MODERATESiemens Dimension Tacrolimus Flex Reagent CartridgeSiemens is recalling Dimension Tacrolimus Flex reagent cartridges due to a potential positive bias in test results.
FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH A1c_E assay due to a risk of depressed results when used alongside the RCRP assay on the same analyzer.
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.