The Recall Desk

Hazard

False Positive Result recalls

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

What the numbers show

Total
44
Critical
0
Severe
0
Most recent
2026-04-29

Of the 44 false positive result recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 result 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.

26–44 of 44

  • HighFDA (Devices)·Z-2299-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2019·2019-07-10

    Beckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Strips because increased sensitivity causes falsely elevated urobilinogen results.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1353-2019·2019-05-22

    Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference

    Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently treated with Mifepristone.

    Product
    Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2019·2018-11-07

    BioFire FilmArray Blood Culture Identification Test Recall for False Positives

    BioFire Diagnostics is recalling FilmArray Blood Culture Identification tests due to an increased risk of false positive results for Proteus when used with specific blood culture bottles.

    Product
    FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2952-2018·2018-09-05

    Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives

    Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointesti
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1513-2018·2018-05-02

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.

    Product
    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 44226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0418-2018·2018-02-07

    Alere Triage Drugs of Abuse Plus TCA 25 Test Kit Recalled for False Positives

    Alere San Diego, Inc. is recalling specific lots of the Triage Drugs of Abuse Plus TCA 25 Test Kit because they produced unexpected false positive THC results.

    Product
    Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2016·2016-05-11

    bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards

    bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.

    Product
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1230-2016·2016-03-30

    Qiagen QFT TB Antigen Tubes Recalled for Potential Endotoxin Contamination

    Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.

    Product
    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0649-2016·2016-01-20

    Beckman Coulter Recalls iChem 10 SG Urine Chemistry Strips

    Beckman Coulter is recalling iChem 10 SG Urine Chemistry Strips because they may produce false positive leukocyte results for negative samples.

    Product
    iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2015·2015-04-29

    DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability

    DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient results.

    Product
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized w
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1454-2015·2015-04-29

    Focus Diagnostics Recalls Stratify JCV DxSelect Assay Due to False Positive Risk

    Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive results.

    Product
    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1320-2015·2015-04-01

    Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives

    Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.

    Product
    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1001-2015·2015-01-28

    Genetic Testing Institute Recalls PF4 Concentrated Wash Reagent Lots

    Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.

    Product
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2013·2013-05-22

    Medtox Diagnostics Recalls PROFILE-V MEDTOXScan Drugs of Abuse Test System

    Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.

    Product
    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2013·2012-10-31

    Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity

    Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.

    Product
    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for ide
    Category
    Medical Device
    Distribution
    Distributed nationwide