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.

51–54 of 54

  • ModerateFDA (Devices)·Z-1843-2014·2014-07-02

    BioFire FilmArray Blood Culture Identification Panel Recalled for False Positives

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

    Product
    FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is gro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1088-2014·2014-03-05

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.

    Product
    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2014·2014-03-05

    Ortho VITROS Sodium Slides Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.

    Product
    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems a
    Category
    Medical Device
    Distribution
    Distributed nationwide