Siemens Healthcare Diagnostics, Inc. recalls
17 recalls filed under Siemens Healthcare Diagnostics, Inc.. The most recent was published October 7, 2026.
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Class II · 18 days ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Revised C-Reactive Protein recall: The potential for falsely elevated results
The potential for falsely elevated results.
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay REF: 4Q019UL recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Beckman Coulter recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class III · 2 months ago
Siemens Healthcare Diagnostics, Inc. Syva Emit Disopyramide Assay Enzyme Immunoassay recall: Out-of-specification sodium azide concentration in Syva Emit Disopyramide
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not…
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin REF: 11537225 recall: Processing of urine albumin assay on the CI analyzers may lead
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results…
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Class III · 2 months ago
Siemens Healthcare Diagnostics, Inc. Syva Emit tox Serum Tricyclic Antidepressant recall: out-of-specification sodium azide concentration in Syva Emit Tox Serum
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results…
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Class II · 3 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c . Material recall: The potential for intermittent well-to-well bias on the A1c_E assay
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…
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Class II · 4 months ago
Siemens Dimension Tacrolimus Flex Reagent Cartridge , REF DF207 recall: A potential positive bias in quality control (QC) and patient sample results
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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Class II · 6 months ago
Siemens Healthcare Diagnostics Inc epoc BGEM BUN Test Card for the epoc Blood recall: Use of the affected product can result in discrepant low pH and measured
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in…
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Class II · 6 months ago
Siemens Healthcare Diagnostics, Inc. Dimension Creatinine Flex reagent cartridge recall: Siemens Healthcare Diagnostics is recalling certain lots of Dimension
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential…
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Class II · 7 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c recall: A potential for depressed results for Atellica CH A1c_E when processing
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on…
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Class II · 8 months ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urine Albumin . Material Number recall: Falsely depressed UAlb patient results may occur. Affected samples with any
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL…
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Class II · 11 months ago
Siemens Healthcare Diagnostics, Inc. Immulite 2000 Oak Mix Specific Allergen recall: The barcode orientation on affected devices causes incorrect scanning order
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 /…
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Class II · 11 months ago
Siemens Healthcare Diagnostics, Inc. 3gAllergy Specific IgE Universal Kit recall: The barcode orientation on affected devices causes incorrect scanning order
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 /…
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Class II · 11 months ago
Siemens Healthcare Diagnostics, Inc. Food Panel 3 Specific Allergen recall: The barcode orientation on affected devices causes incorrect scanning order
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 /…
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Class II · 12 months ago
Siemens Healthcare Diagnostics, Inc. Assay: Immulite 2000 Intact PTH recall: The potential for falsely depressed Intact PTH patient results at the low end
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal…
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Class II · 1+ years ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein recall: Potential for falsely depressed patient, quality control (QC)
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
About this page
Siemens Healthcare Diagnostics, Inc. appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.