The Recall Desk

Hazard

Inaccurate Results recalls

469 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
469
Critical
0
Severe
6
Most recent
2026-09-02

Of the 469 inaccurate results recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (1%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate results recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 469

  • HighFDA (Devices)·Z-1688-2020·2020-04-15

    Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias

    Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.

    Product
    "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1672-2020·2020-04-15

    Qualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results

    Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.

    Product
    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2020·2020-04-08

    Binding Site C-Reactive Protein Kit Recalled for Reagent Performance Issues

    The Binding Site Group is recalling C-Reactive Protein Kits because a reagent is not performing to specification, potentially affecting low-concentration samples.

    Product
    C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1599-2020·2020-04-01

    Siemens Atellica CH Ethyl Alcohol Assay Recalled for Calibration Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Ethyl Alcohol assays due to potential positive bias in results within the 10-day calibration interval.

    Product
    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2020·2020-04-01

    Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Direct Bilirubin assays because they may show inaccurate results for patients taking eltrombopag.

    Product
    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2020·2020-04-01

    Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate high results for patients taking eltrombopag.

    Product
    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2020·2020-04-01

    Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.

    Product
    Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2020·2020-03-11

    Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects

    Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.

    Product
    Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2020·2020-02-26

    Siemens ADVIA Chemistry Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.

    Product
    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2020·2020-02-19

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for Potential Sodium Bias

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 units due to a potential for negatively biased sodium (Na+) urine results.

    Product
    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0862-2020·2020-02-05

    Siemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error

    Siemens is recalling 1,528 Atellica CH 930 Analyzers in 17 foreign countries because a barcode scanning error causes the system to use default values instead of specific fluid concentrations for Sodium, Potassium, and Chloride tests.

    Product
    Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0830-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Interference

    Siemens is recalling ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0829-2020·2020-01-29

    Siemens ADVIA Centaur Folate 100 Test Kits Recalled for Elevated Results

    Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0831-2020·2020-01-29

    Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Cross-Reactivity

    Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.

    Product
    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2020·2020-01-01

    PTS Test Strips Recalled for Under-Recovery Against Reference Method

    Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.

    Product
    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0173-2020·2019-10-30

    Abbott Recalls Emerald Diluent Tubing Due to Cloudiness and Film

    Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers with diluent tubing that appears cloudy or has a film, which may cause falsely elevated platelet results.

    Product
    Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0074-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Counts

    Becton, Dickinson and Company is recalling 22 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0042-2020·2019-10-16

    Roche Vancomycin Test Recall Due to Inaccurate Low Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0067-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recalled for Potential False Absolute Counts

    Becton, Dickinson and Company is recalling specific BD FACSLyric Flow Cytometers used with BD Trucount Tubes due to potential electronic errors that may result in falsely high absolute cell counts.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0072-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 30 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0070-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0043-2020·2019-10-16

    Roche Online TDM Vancomycin Gen.3 Recalled for Inaccurate Low Sample Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 kits because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0073-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0066-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recalled for Potential False High Counts

    Becton, Dickinson and Company is recalling 12 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0068-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states