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.

176–200 of 667

  • HighFDA (Devices)·Z-0863-2021·2021-01-20

    Siemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2021·2020-12-30

    Siemens ADVIA GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.

    Product
    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0722-2021·2020-12-30

    Siemens Atellica GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.

    Product
    Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2021·2020-11-25

    Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

    Product
    Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2021·2020-10-28

    Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.

    Product
    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)0063041459916
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2021·2020-10-28

    Siemens Alkaline Phosphatase Reagent Cartridge Recall for Low Outlier Results

    Siemens Healthcare Diagnostics is recalling Alkaline Phosphatase (ALPI) Flex reagent cartridges due to low outlier test results. The recall covers 5,970 US units and 1,446 international units.

    Product
    Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2021·2020-10-21

    Siemens ADVIA Fructosamine Test Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.

    Product
    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0102-2021·2020-10-21

    Siemens Atellica CH Fructosamine Test Recall for Positive Bias

    Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.

    Product
    Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0052-2021·2020-10-14

    Siemens Troponin I Reagent Cartridge Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Dimension LOCI High Sensitivity Troponin I reagent cartridges due to positive bias in test results.

    Product
    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2927-2020·2020-09-09

    Siemens Dimension Vista Troponin I Reagent Cartridge Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista High Sensitivity Troponin I reagent cartridges because they may exhibit a negative bias with patient samples.

    Product
    Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2747-2020·2020-08-12

    Siemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues

    Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.

    Product
    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2020·2020-07-08

    Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.

    Product
    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2020·2020-07-08

    Siemens IMMULITE 2000 XPi Analyzer Recalled for Tubing Crack Risk

    Siemens Healthcare Diagnostics Inc. is recalling 2,925 IMMULITE 2000 XPi Immunoassay Systems because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2020·2020-07-08

    Siemens IMMULITE 2000 Analyzer Recalled for Tubing Crack Hazard

    Siemens Healthcare Diagnostics is recalling 1,555 IMMULITE 2000 analyzers because flexible tubing can crack, causing liquid waste leaks and slip hazards.

    Product
    Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2020·2020-07-08

    Siemens CentraLink Software Recalled for Potential Erroneous Patient Results

    Siemens Healthcare Diagnostics is recalling CentraLink Data Management System software versions 16.0.2 and 16.0.3 due to a defect that may cause erroneous patient results.

    Product
    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolida
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2020·2020-07-01

    Siemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues

    Siemens is recalling Atellica Solution IM1600 Analyzers because insufficient sample volumes may not be detected when using specific sample cups.

    Product
    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2404-2020·2020-07-01

    Siemens Atellica IM1300 Analyzer Recall for Insufficient Sample Detection Failure

    Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.

    Product
    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-2430-2020·2020-07-01

    Siemens ADVIA Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lots 534177 and 534179 due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    ADVIA Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2020·2020-07-01

    Siemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrators due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    Atellica CH Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2020·2020-07-01

    Siemens RP500e Handheld Barcode Scanner Recalled for Data Integrity Failure

    Siemens Healthcare Diagnostics Inc. is recalling 436 RP500e Handheld Barcode Scanners because they fail to verify Code 39 barcode data integrity using check-digits.

    Product
    RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2284-2020·2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2020·2020-06-17

    Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.

    Product
    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2020·2020-06-17

    Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide