The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

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.

About this listing

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.

126–150 of 667

  • HighFDA (Devices)·Z-0929-2022·2022-04-20

    Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues

    Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2022·2022-04-20

    Siemens Atellica CH Lithium reagent recalled for potential reagent carryover

    Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2022·2022-04-20

    Siemens Atellica CH Calcium_2 Reagent Carryover Recall

    Siemens is recalling Atellica CH Calcium_2 diagnostic reagent due to potential reagent carryover that could impact quality control, patient samples, and calibrator results. The recall affects approximately 2,395 units distributed globally and in the US.

    Product
    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2022·2022-04-20

    Siemens Atellica CH Fructosamine Reagent Recalled for Potential Carryover

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.

    Product
    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2022·2022-04-06

    Siemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors

    Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.

    Product
    Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2022·2022-01-12

    Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results

    Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.

    Product
    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2022·2022-01-05

    Siemens Atellica CH β2-Microglobulin Assay Lot 211446 Recalled for Measurement Bias

    Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.

    Product
    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2022·2021-12-08

    Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

    Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

    Product
    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2022·2021-12-08

    Siemens Dimension Vista 500 software issue affects test accuracy

    Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

    Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2022·2021-11-10

    Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data

    Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.

    Product
    Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2022·2021-11-10

    Siemens Aptio Interface Module may misassociate laboratory test results

    Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.

    Product
    Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2022·2021-11-10

    ADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data

    Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.

    Product
    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2022·2021-11-03

    Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results

    Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.

    Product
    Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2022·2021-11-03

    Siemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results

    Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0124-2022·2021-10-27

    Atellica IM 1300 Analyzer Reagent Overflow at High Altitudes

    Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.

    Product
    Atellica IM 1300 Analyzer, SMN 11066001
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2426-2021·2021-09-15

    Medical diagnostic kit requires more frequent calibration than Instructions stated

    The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2021·2021-09-15

    Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency

    Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.

    Product
    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2021·2021-09-15

    Medical Device Test Kit Requires More Frequent Calibration Than Labeled

    Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.

    Product
    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2021·2021-07-14

    Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect

    Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.

    Product
    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2021·2021-07-14

    Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk

    Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.

    Product
    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2021·2021-07-14

    Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy

    Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.

    Product
    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2021·2021-07-14

    ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results

    Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.

    Product
    The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2021·2021-06-23

    Atellica CH 930 Analyzer photometer lamp may produce inaccurate results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with photometer lamps that may reach saturation without alerting users, potentially producing inaccurate patient test results.

    Product
    Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2021·2021-06-02

    Siemens Centaur Syphilis Assay Recalled for Potential Carryover Interference

    Siemens Healthcare Diagnostics is recalling the Centaur Syphilis Assay-SYP Kit due to potential carryover into other assays on specific systems.

    Product
    Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
    Category
    Medical Device
    Distribution
    Distributed nationwide