Siemens Healthcare Diagnostics, Inc. recalls
12 recalls.
- Atellica CH Revised C-Reactive Protein recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported October 7, 2026 · The potential for falsely elevated results. - Beckman Coulter recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Atellica CH Urine Albumin REF: 11537225 recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 12, 2026 · 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... - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 ... recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIIReported August 12, 2026 · out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not... - Syva Emit Disopyramide Assay Enzyme Immunoassay recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIIReported August 12, 2026 · Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the... - Atellica CH Enzymatic Hemoglobin A1c recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported July 15, 2026 · 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... - Siemens Dimension Tacrolimus Flex Reagent Cartridge recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported June 17, 2026 · A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. - epoc BGEM BUN Test Card recall (Siemens Healthcare Diagnostics Inc)
Medical deviceClass IIReported May 6, 2026 · Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial... - Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported May 6, 2026 · Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the... - Atellica CH Enzymatic Hemoglobin A1c recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported April 8, 2026 · 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 separate... - Atellica CH Urine Albumin recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported March 11, 2026 · Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may...