Manufacturer
667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.
Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Siemens Healthcare Diagnostics is recalling Lot U2 of its Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls due to an out-of-specification sodium azide concentration. The recall affects 494 units in the US and 114 units overseas, distributed nationwide and internationally.
Siemens Healthcare Diagnostics is recalling Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1 due to out-of-specification sodium azide concentration.
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Siemens Healthcare Diagnostics is recalling all lots of the Atellica CH Urine Albumin assay because falsely depressed patient results may occur above the measuring interval.
Siemens Healthcare Diagnostics is recalling 34 units of IMMULITE 2000 Oak Mix Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
Siemens Healthcare Diagnostics is recalling 2,802 units of the 3gAllergy Specific IgE Universal Kit because barcode orientation causes the instrument to misread tube positions.
Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.
Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
Siemens Healthcare Diagnostics is recalling Atellica CH Diluent (SMN 11099300, Lot 0000195412) due to contamination with sodium hypochlorite, which may affect laboratory test results.
Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.
Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.