The Recall Desk

Hazard

False Positive Results recalls

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

What the numbers show

Total
54
Critical
1
Severe
3
Most recent
2026-05-20

Of the 54 false positive results recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (6%) 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 false positive 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.

26–50 of 54

  • SevereFDA (Devices)·Z-0007-2022·2021-10-20

    Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives

    Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.

    Product
    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2498-2021·2021-09-29

    cobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results

    Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.

    Product
    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2021·2021-09-22

    FDA Recalls Luminex Verigene Enteric Pathogen Test Kits for False Positive Results

    Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.

    Product
    Verigene EP Amplification Reagent Kit Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.

    Product
    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2021·2021-07-07

    NeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results

    NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.

    Product
    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1267-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.

    Product
    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2021·2021-02-24

    LumiraDx SARS-CoV-2 Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips due to potential false positive results that could lead to unnecessary treatment or quarantine.

    Product
    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. I
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0846-2021·2021-01-20

    Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk

    Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.

    Product
    The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2021·2020-10-28

    Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors

    Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.

    Product
    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2020·2020-08-12

    BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results

    Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.

    Product
    BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasophar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2020·2020-04-29

    Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives

    Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.

    Product
    The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2135-2019·2019-08-07

    Siemens Stratus CS Acute Care cTNI TestPak Recalled for False Positives

    Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.

    Product
    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2019·2019-05-22

    Abbott Alinity i Estradiol Reagent Kit Recalled for False Results

    Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.

    Product
    Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2019·2019-05-08

    BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results

    BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.

    Product
    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with Fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2019·2019-04-24

    BioFire FilmArray BCID Panel Recall for False Positive Blood Culture Results

    BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.

    Product
    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2944-2018·2018-09-05

    Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk

    Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.

    Product
    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for u
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1063-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.

    Product
    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2017·2017-01-25

    Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results

    Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.

    Product
    PREMIER EHEC and PREMIER EHEC Bulk.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2016·2016-06-01

    Ortho-Clinical Diagnostics Recalls VITROS Total Beta-hCG II Reagent Packs

    Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.

    Product
    1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2015·2015-06-24

    BD Viper LT System Recalled for Potential False Positive Diagnostic Results

    Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.

    Product
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1457-2015·2015-04-29

    Siemens ADVIA Chemistry Lipase Reagent Recalled for Carryover Contamination

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase Reagent because carryover from other reagents can cause falsely elevated test results.

    Product
    ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0171-2015·2014-11-19

    Siemens MicroScan Rapid Urine Combo Panel Recalled for False Positive Results

    Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.

    Product
    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultativel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2015·2014-11-19

    Siemens MicroScan Rapid Neg BP Combo Panel Type 3 Recalled for False Positives

    Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.

    Product
    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
    Category
    Medical Device
    Distribution
    Distributed nationwide