The Recall Desk

Hazard

False Negatives recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2024-09-25

Of the 5 false negatives 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 negatives 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.

1–5 of 5

  • HighFDA (Devices)·Z-3169-2024·2024-09-25

    Siemens Atellica Microalbumin Diagnostic Test Kits Recalled for Measurement Error

    Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.

    Product
    Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2024·2023-12-13

    Blood Ketone Test Strips Recalled for False Negative Results

    Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.

    Product
    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2023·2023-04-26

    BioFire FilmArray GI Panel Recalled for Potential False Negative Results

    BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.

    Product
    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2021·2021-06-30

    Blood Culture Identification Panel Recalled Due to Manufacturing Defect

    BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.

    Product
    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
    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