The Recall Desk

Hazard

False Positives recalls

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

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2023-08-09

Of the 6 false positives recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (17%) 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 positives 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.

1–6 of 6

  • HighFDA (Devices)·Z-2255-2023·2023-08-09

    NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk

    NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.

    Product
    NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2023·2022-12-28

    Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results

    Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.

    Product
    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0005-2022·2021-10-20

    Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results

    Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk

    Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.

    Product
    ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2021·2021-06-30

    FilmArray Pneumonia Panel diagnostic test kits recalled for false results

    BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.

    Product
    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide