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.

101–125 of 667

  • HighFDA (Devices)·Z-0718-2023·2022-12-21

    Siemens allergy test kits recalled for false mold allergen reactivity results

    Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2023·2022-12-21

    Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results

    Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0716-2023·2022-12-21

    Siemens Allergen Test Kit Recall: False Positive Mold Results

    Siemens is recalling IMMULITE 2000 allergen test kits that may produce false positive results for mold allergies in both quality control and patient samples.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2023·2022-12-14

    Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias

    Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.

    Product
    IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2023·2022-10-26

    Dimension Vista HDLC Reagent Cartridge Recalled for Inaccurate Lab Results

    Siemens is recalling 1,592 units of Dimension Vista HDLC reagent cartridges due to potential for erroneous test results. Affected cartridges may produce falsely high or low HDL cholesterol measurements.

    Product
    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2023·2022-10-26

    Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer

    The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2023·2022-10-26

    N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards

    Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.

    Product
    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2023·2022-10-26

    Siemens N Antiserum to Human IgG Recall for High-Dose Performance Failure

    Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.

    Product
    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2023·2022-10-26

    Medical device assay may report falsely elevated lithium levels

    Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.

    Product
    Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2022·2022-10-05

    Siemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results

    Siemens is recalling IMMULITE 2000 and XPi Thyroid Stimulating Immunoglobulins test kits due to a -23% negative bias that may produce falsely low results, potentially delaying diagnosis of autoimmune thyroid disease.

    Product
    IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2022·2022-10-05

    Siemens Magnesium Test Cartridges May Produce Erroneous Results Without Alert

    Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.

    Product
    Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2022·2022-09-07

    Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.

    Product
    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2022·2022-08-10

    Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover

    Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.

    Product
    Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2022·2022-07-20

    Blood gas test device recalled for inaccurate oxygen measurements

    Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.

    Product
    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1341-2022·2022-07-13

    Cardiac Troponin Diagnostic Test Recalled for Positive Bias in Plasma Samples

    Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.

    Product
    Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2022·2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2022·2022-06-15

    Siemens Atellica IM 1600 Analyzer Recalled for Potential Erroneous Test Results

    Siemens recalled 2,321 Atellica IM 1600 Analyzers due to incompatibility with Test Definition Version 1.4, which may produce erroneous total T3 test results. Worldwide distribution affected.

    Product
    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1252-2022·2022-06-15

    Atellica IM 1300 Analyzers Incompatible with Software Can Produce Erroneous Thyroid Results

    Siemens is recalling 1,566 Atellica IM 1300 Analyzers distributed worldwide because certain lots are incompatible with Test Definition version 1.4 and may generate incorrect total T3 thyroid test results.

    Product
    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2022·2022-05-11

    Medical Diagnostic Test Kit Issues Falsely Elevated Estradiol Results

    Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2022·2022-05-11

    Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results

    An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2022·2022-05-11

    Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2022·2022-05-11

    In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.

    Product
    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2022·2022-05-11

    Estradiol diagnostic test kits recalled for falsely elevated results

    Siemens Atellica IM Enhanced Estradiol test kits can produce falsely elevated results in plasma specimens, potentially leading to misinterpretation of patient hormone measurements. Approximately 2,044 units worldwide are affected.

    Product
    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2022·2022-05-11

    Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.

    Product
    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2022·2022-05-04

    IMMULITE 2000 hCG diagnostic systems recalled for falsely elevated results

    Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.

    Product
    IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
    Category
    Medical Device
    Distribution
    Distributed nationwide