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.

351–375 of 469

  • ModerateFDA (Devices)·Z-1931-2015·2015-07-08

    Roche Uric Acid Plus Test Recalled for Drug Interference

    Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

    Product
    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2015·2015-07-08

    Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits

    Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.

    Product
    Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.

    Product
    LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.

    Product
    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2015·2015-07-08

    Roche Triglycerides GPO Test Recalled for Potential Drug Interference

    Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.

    Product
    Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2015·2015-07-08

    Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.

    Product
    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2015·2015-06-17

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.

    Product
    VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2015·2015-06-10

    Siemens Dade Actin Activated Cephaloplastin Reagent Recalled for Out-of-Range Results

    Siemens Healthcare Diagnostics is recalling Dade Actin Activated Cephaloplastin Reagent because assay controls are out of assigned ranges, potentially causing inaccurate APTT test results.

    Product
    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1708-2015·2015-06-10

    Siemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results

    Siemens is recalling 2,256 units of the Dimension Vista LOCI TSH test due to a defect that may cause falsely low results.

    Product
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2015·2015-05-27

    Siemens IMMULITE TBG Test Kits Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling 155 IMMULITE TBG test kits because they may produce falsely low thyroid test results.

    Product
    IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1622-2015·2015-05-27

    Roche Homocysteine Test System Recalled for Inaccurate Low Results

    Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.

    Product
    Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2015·2015-05-20

    Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1398-2015·2015-04-15

    Siemens QuikLYTE Dilution Check Recalled for Potential Result Bias

    Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.

    Product
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE modul
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1375-2015·2015-04-08

    BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination

    BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.

    Product
    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1293-2015·2015-03-25

    Radiometer Crea A and B Membranes Recalled for Negative QC Drift

    Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.

    Product
    Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1255-2015·2015-03-18

    Siemens RAPIDLab 1265 System Recalled for Neonatal Bilirubin Variability

    Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results

    Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias

    Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.

    Product
    ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2015·2015-02-11

    Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors

    Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.

    Product
    ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-0881-2015·2015-01-14

    Alere INRatio Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.

    Product
    INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2015·2014-12-31

    Siemens Dimension Vista Lab Systems Recalled for Reagent Performance Issues

    Siemens Healthcare Diagnostics is recalling Dimension Vista 500 and 1500 systems due to reagent probe performance decline that may affect patient and QC results.

    Product
    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analyte
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0474-2015·2014-12-03

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors

    Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.

    Product
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2015·2014-11-12

    Siemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays

    Siemens Healthcare Diagnostics is recalling Calibrator E kits due to positive bias in Cortisol and Progesterone assays on ADVIA Centaur Systems.

    Product
    Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2015·2014-11-05

    Abbott HbA1c Calibrators Recalled for Potential Incorrect Value Sheets

    Abbott Laboratories is recalling HbA1c Calibrators that may contain value sheets for a different lot, which could cause falsely elevated test results.

    Product
    HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: O
    Category
    Medical Device
    Distribution
    0 states